protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Clinical decision support trigger"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Kidney Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Stockholm",
"contacts": [
{
"email": "[email protected]",
"name": "Juan J Carrero, Prof",
"phone": "0046739636948",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Karolinska Institutet",
"geoPoint": {
"lat": 59.33258,
"lon": 18.0649
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "One in 10 adults in Region Stockholm have chronic kidney disease (CKD), which dramatically increases healthcare costs and the risk of medication errors or adverse health outcomes, including cardiovascular disease and death. Identification and early management of these patients is done in primary care settings. However, most adults with CKD in our region are under detected, undiagnosed and undertreated, with low rates of referral to nephrology-specialist care.This is a pragmatic cluster randomized controlled trial (RCT) involving 66 primary healthcare centers in Region Stockholm, and testing the effect of an electronic clinical decision support (CDS) triggering system to assist general practitioners through the guideline-recommended processes of CKD care.The centers, providing healthcare to approximately 780.000 citizens, will be randomized 50:50 to this CDS trigger (vs basic advice) for 18 months. Study outcomes will consider the improvement in the indicators of CKD care.As a pragmatic trial there is no active recruitment or active data collection. The trial is embedded into the ongoing Stockholm CREAtinine Measurements (SCREAM) project, a database collection of healthcare use for the complete population of Stockholm. Using this real-world healthcare data collection, the investigators will be able to measure with precision the impact of our CDS trigger and its potential to improve clinical care."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The primary healthcare network system of the region of Stockholm coordinates 66 public primary healthcare centers. Collectively, these centers offer care to an estimated population of 780.000. Since November 2022, a new platform for CDS (clinical decision support) triggers called ALMA has been implemented in these centers. ALMA is connected to patient records and uses CDS triggers to identify medical problems, issue alerts and propose solutions.Using the ALMA platform, this project has the following objectives:Objective 1: to develop a CDS trigger connected with the electronic healthcare records specific to the processes of screening, diagnosis, and nephrologist referral of patients with CKD, including individualized CKD management optimization, in primary care.Objective 2: to evaluate the effectiveness of this CDS trigger (versus current basic advice) through a 2-arm pragmatic cluster RCT.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 780000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ALMA-CKD",
"briefTitle": "Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm",
"nctId": "NCT06386172",
"orgStudyIdInfo": {
"id": "2023-03537-01",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ALF Medicin, Region Stockholm",
"id": "FoUI-986028",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants screened for creatinine and albuminuria"
},
{
"measure": "Number of screened participants with retesting for creatinine and albuminuria"
}
],
"secondaryOutcomes": [
{
"measure": "Number of participants with laboratory-determined CKD receiving a clinical diagnosis"
},
{
"measure": "Number of participants receiving CKD-modifying agents"
},
{
"measure": "Number of participants referred to nephrologist care"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Danderyd Hospital"
},
{
"name": "Region Stockholm"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Karolinska Institutet"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-09"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2024-04-01",
"filename": "SAP_000.pdf",
"hasIcf": false,
"hasProtocol": false,
"hasSap": true,
"label": "Statistical Analysis Plan",
"size": 292236,
"typeAbbrev": "SAP",
"uploadDate": "2024-04-23T02:35"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Electrical vagus nerve stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Post-extubation Dysphagia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Feng Feng, Xiuqin",
"phone": "13757119151",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Feng Xiuqin",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": null,
"status": "RECRUITING",
"zip": "310000"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to establish a practical comprehensive intervention program for dysphagia after extubation in adult ICU patients based on the best evidence of its assessment and intervention, through expert panel discussion and Delphi method. In addition, combining the preliminary experimental results of vagus nerve stimulation applied to PED patients, we further develop a comprehensive intervention program for dysphagia after extubation based on neural regulation mechanism. Finally, the implementation effect of this PED comprehensive intervention program based on neural regulation mechanism will be verified through clinical application."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 69,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism",
"nctId": "NCT06386159",
"orgStudyIdInfo": {
"id": "2023-1178",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "functional oral intake scale（FOIS）"
},
{
"measure": "standardized Swallowing Assessment（SSA）"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of total oral feeding after the intervention"
},
{
"measure": "Duration of Enteral Nutrition Tube Indwelling"
},
{
"measure": "Rate of Re-intubation after Endotracheal Intubation"
},
{
"measure": "Incidence of aspiration within one week after extubation"
},
{
"measure": "The incidence of aspiration pneumonia within one week after extubation"
},
{
"measure": "Inflammation-related indicators: serum C-reactive protein (CRP)"
},
{
"measure": "Inflammation-related indicators: serum interleukin-6 (IL-6)"
},
{
"measure": "Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh)"
},
{
"measure": "Inflammation-related indicators: high mobility group box-1 protein (HMGB1)"
},
{
"measure": "Days of ICU hospitalization"
},
{
"measure": "Total days of hospitalization"
},
{
"measure": "In-hospital survival rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Second Affiliated Hospital, School of Medicine, Zhejiang University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "JAB-30355"
},
{
"name": "JAB-30355"
}
]
},
"conditionsModule": {
"conditions": [
"Solid Tumors"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 144,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation",
"nctId": "NCT06386146",
"orgStudyIdInfo": {
"id": "JAB-30355-1001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dose limiting toxicity (DLT)"
},
{
"measure": "Number of participants with adverse events"
}
],
"secondaryOutcomes": [
{
"measure": "Peak Plasma Concentration (Cmax)"
},
{
"measure": "Time to reach the observed maximum (peak) concentration (Tmax)"
},
{
"measure": "Terminal half-life (t1/2)"
},
{
"measure": "Objective response rate (ORR)"
},
{
"measure": "Duration of response (DOR)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Jacobio Pharmaceuticals Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MS Boost"
},
{
"name": "Standard of care"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis",
"Fatigue Syndrome, Chronic"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The main objective of the MS Boost study is to demonstrate the superiority of MSCopilot Boost over standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis (MS).The secondary objectives include validating MSCopilot Boost clinical performance in reducing fatigue and its impact as well as evaluating its functional tests performance and its safety of use. The investigation team will also investigate the effects of MSCopilot Boost on patient symptoms, functional parameters and physical activity levels. The investigation team will evaluate patients and healthcare professionals' perceived clinical benefit as well as adherence, satisfaction and user experience related to the mobile application and the web portal. Ultimately, the investigation team will define the medico-economic and organizational impact of the MSCopilot Boost solution.Patients' expected benefits are the access to additional clinical tests not routinely performed, covering dimensions not addressed by standard tests like the EDSS for example; a remote monitoring of functional tests similar to those of the modified MSFC with the possibility of adding an evaluation of fatigue through digital questionnaires; improvement of symptoms related to MS fatigue through access to a personalised tele-rehabilitation program.Healthcare professionals' expected benefits are to track objective measures of key functional symptoms of the disease between consultations, supporting MS patients' management and to gain time by providing a \"big picture\" of the patient's condition over time."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Boost group: Use of MSCopilot Boost and wear of an actimeter during the whole study participation duration.Control group: Standard practice and wear of an actimeter during the whole study participation duration.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 208,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MSBoost",
"briefTitle": "Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compared to Standard Care",
"nctId": "NCT06386133",
"orgStudyIdInfo": {
"id": "MS Boost",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "To evaluate the link between MSCopilot Boost use compliance and fatigue improvement."
},
{
"measure": "To assess the relationship between self-reported and objectively measured physical activity."
},
{
"measure": "To explore the factors that might influence the effect of MSCopilot Boost on fatigue and its impact."
},
{
"measure": "To assess the changes in sleep patterns and areas of life impacted by fatigue, as measured with MSCopilot Boost at home."
},
{
"measure": "To assess the evolution of overall physical activity reported by patients."
},
{
"measure": "To explore the correlation between overall physical activity and the change in : -Fatigue impact -Fatigue"
},
{
"measure": "Calculation of cost-effectiveness in reducing fatigue at 1, 3, 6 and 9 months using MSCopilot Boost as an intervention, compared to standard care."
},
{
"measure": "To assess the impact of MSCopilot Boost on work-related factors (duration without working, absenteeism from work, return-to-work time, presenteeism) at 3, 6 and 9 months, compared to baseline (Day 0), in both groups."
},
{
"measure": "To evaluate behavioral changes in terms of physical activity and energy management."
}
],
"primaryOutcomes": [
{
"measure": "To demonstrate that MSCopilot Boost is superior to standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis"
}
],
"secondaryOutcomes": [
{
"measure": "To evaluate the impact of fatigue in both groups."
},
{
"measure": "To compare the effect of MSCopilot Boost in reducing fatigue impact compared to standard practice (Short term and Medium term)"
},
{
"measure": "To compare the fatigue impact between the two groups."
},
{
"measure": "To compare the effect of MSCopilot Boost in reducing perceived fatigue compared to standard practice."
},
{
"measure": "Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital."
},
{
"measure": "Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterparts performed under supervised conditions at the hospital."
},
{
"measure": "Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital."
},
{
"measure": "Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital."
},
{
"measure": "Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital."
},
{
"measure": "Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital"
},
{
"measure": "Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital"
},
{
"measure": "Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital"
},
{
"measure": "Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital"
},
{
"measure": "Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital"
},
{
"measure": "Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home."
},
{
"measure": "Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home."
},
{
"measure": "Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home."
},
{
"measure": "Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home."
},
{
"measure": "To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home."
},
{
"measure": "To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home."
},
{
"measure": "To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home."
},
{
"measure": "To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home."
},
{
"measure": "To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home."
},
{
"measure": "To assess the number of adverse events of using MSCopilot Boost."
},
{
"measure": "To compare the effect of MSCopilot Boost on walking compared to standard practice: -Assessed by the functional standard test performed at the hospital -Assessed at home"
},
{
"measure": "To compare the proportion of patients whose symptoms improved in both groups on Fatigue impact."
},
{
"measure": "To compare the proportion of patients whose symptoms improved in both groups on anxiety and depression."
},
{
"measure": "To compare the proportion of patients whose symptoms improved in both groups on Depression."
},
{
"measure": "To compare the proportion of patients whose symptoms improved in both groups on Fatigue."
},
{
"measure": "To compare the proportion of patients whose symptoms improved in both groups on Walking."
},
{
"measure": "To compare the proportion of patients whose symptoms improved in both groups on Dexterity."
},
{
"measure": "To compare the proportion of patients whose symptoms improved in both groups on Cognition."
},
{
"measure": "To compare the proportion of patients whose symptoms improved in both groups on the Low-contrast Vision."
},
{
"measure": "To compare the effect of MSCopilot Boost on quality of life compared to standard practice."
},
{
"measure": "To compare the effect of MSCopilot Boost on the mean overall physical activity compared to standard practice."
},
{
"measure": "To evaluate the satisfaction and user experience of both patients and healthcare professionals regarding MSCopilot Boost."
},
{
"measure": "To assess the clinical benefit of MSCopilot Boost reported by patients and healthcare professionals."
},
{
"measure": "To assess the organizational impact of MSCopilot Boost as reported by healthcare professionals."
},
{
"measure": "To assess user compliance with MSCopilot Boost throughout the follow-up period."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Assistance Publique - Hôpitaux de Paris"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Ad scientiam"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PEEP setting strategy"
}
]
},
"conditionsModule": {
"conditions": [
"Lung Contusion"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to learn about EIT in observing the application of lung protective ventilation strategies in patients with pulmonary contusion, particularly the impact on pulmonary ventilation blood flow ratio, oxygen, and condition. The main question it aims to answer is:Can lung protective ventilation strategies improve respiratory function in patients with severe chest contusion? We will collect clinical data of participants who already taking lung protective ventilation strategies as part of their regular medical care."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Respiratory Function Monitoring of Mechanical Ventilation in Patients With Chest Blunt Injury",
"nctId": "NCT06386120",
"orgStudyIdInfo": {
"id": "2024-z033",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "ventilation blood flow ratio"
}
],
"secondaryOutcomes": [
{
"measure": "oxygenation index"
},
{
"measure": "28-day mortality"
},
{
"measure": "Mechanical ventilation-free from day 1 to 28"
},
{
"measure": "Length of ICU stay"
},
{
"measure": "Length of hospital stay"
},
{
"measure": "The rate of successful weaning"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Peking University People's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Thrombin Generation Assay (TGA)"
}
]
},
"conditionsModule": {
"conditions": [
"Cancer",
"Pulmonary Embolism",
"Thrombosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Clermont-Ferrand",
"contacts": [
{
"email": null,
"name": "Jeannot SCHMIDT, MD PHD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jeannot SCHMIDT, MD PHD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Aurélien LEBRETON, MD PHD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Fares MOUSTAFA, MD PHD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Nicolas DUBLANCHET, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Dorian TEISSANDIER, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "France",
"facility": "Chu Clermont-Ferrand",
"geoPoint": {
"lat": 45.77966,
"lon": 3.08628
},
"state": null,
"status": null,
"zip": "63003"
},
{
"city": "Grenoble",
"contacts": [
{
"email": "[email protected]",
"name": "Gilles PERNOD, MD PHD",
"phone": "04 76 76 57 17",
"phoneExt": "+33",
"role": "CONTACT"
},
{
"email": null,
"name": "Gilles PERNOD, MD PHD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Raphaël MARLU, MD PHD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "France",
"facility": "CHU de Grenoble",
"geoPoint": {
"lat": 45.16667,
"lon": 5.71667
},
"state": null,
"status": null,
"zip": "38043"
},
{
"city": "Lyon",
"contacts": [
{
"email": null,
"name": "Yesim DARGAUD, MD PHD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Judith CATELLA, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Claire GRANGE, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Yesim DARGAUD, MD PHD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "France",
"facility": "HCL",
"geoPoint": {
"lat": 45.74848,
"lon": 4.84669
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Saint-Étienne",
"contacts": [
{
"email": "[email protected]",
"name": "Géraldine POENOU, MD PHD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Laurent BERTOLETTI, MD PHD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Xavier DELAVENNE, MD PHD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Coline LEGENDRE, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Pauline NOYEL, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Brigitte TARDY, MD PHD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Géraldine POENOU, MD PHD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Chu St-Etienne",
"geoPoint": {
"lat": 45.43389,
"lon": 4.39
},
"state": null,
"status": null,
"zip": "42055"
}
]
},
"descriptionModule": {
"briefSummary": "Pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. In patients with cancer-associated thrombosis (CAT), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. Most of the guidelines propose to integrate the bleeding risk in the choice of therapies. Thrombin generation assay (TGA) reflects an overall hemostatic response and could be a useful biomarker. Proven on the thrombotic side in the CAT population, useful in the assessment of the bleeding risk of hemophiliac patients, the TGA is emerging as a tool. The investigators to measure TGA in cancer patients included prospectively, having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Prospective cohort of consecutive patients initiating full-dose anticoagulant therapy for an episode of CAT, followed up until the 6th month of treatment to assess the risk of clinically relevant adjunctive bleeding events and any other adverse event during anticoagulant therapy (recurrence of CAT, death).TGT measurement is fully automated and calibrated with quality control.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 212,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CATforCAT",
"briefTitle": "Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis",
"nctId": "NCT06386107",
"orgStudyIdInfo": {
"id": "23PH188",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ANSM",
"id": "2023-A02175-40",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The measurement of the area under the curve ( endogenious thrombin potential) nMxmin"
},
{
"measure": "the measurement of the lag time unit = seconds"
},
{
"measure": "the measurement of the peak height unit = nm"
},
{
"measure": "the measurement of the time to peak unit = seconds"
}
],
"secondaryOutcomes": [
{
"measure": "Effect of adding TGT results on the performance of bleeding risk prediction scores"
},
{
"measure": "Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT"
},
{
"measure": "Occurrence of an event of interest under treatment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Diagnostica Stago"
},
{
"name": "LEO Pharma"
},
{
"name": "Ligue contre le cancer, France"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de Saint Etienne"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Echocardiographic assessment"
}
]
},
"conditionsModule": {
"conditions": [
"NAFLD",
"Cardiac Disease",
"Fatty Liver"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chandigarh",
"contacts": [
{
"email": "[email protected]",
"name": "Dr. Madhumita Premkumar, MD",
"phone": "+9101722754777",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "India",
"facility": "Dr. Madhumita Premkumar",
"geoPoint": {
"lat": 30.73629,
"lon": 76.7884
},
"state": null,
"status": "RECRUITING",
"zip": "160012"
}
]
},
"descriptionModule": {
"briefSummary": "Cirrhotic cardiomyopathy is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E/e' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre. The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cardiac Dysfunction in Patients With Non-alcoholic Fatty Liver Disease",
"nctId": "NCT06386094",
"orgStudyIdInfo": {
"id": "INT/IEC/2023/SPL-902",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease"
}
],
"secondaryOutcomes": [
{
"measure": "Presence of myocardial abnormalities in CCM dysfunction"
},
{
"measure": "Presence of perfusion abnormalities in CCM dysfunction"
},
{
"measure": "All cause mortality in NAFLD"
},
{
"measure": "Cardiac event related mortality in NAFLD"
},
{
"measure": "To determine the severity of cardiac dysfunction in patients with non-alcoholic fatty liver disease"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Post Graduate Institute of Medical Education and Research, Chandigarh"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Citrus pectin with low DE"
},
{
"name": "Apple pectin with high DE"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Food Allergy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Malaga",
"contacts": null,
"country": "Spain",
"facility": "Hospital Regional Universitario de Málaga",
"geoPoint": {
"lat": 36.72016,
"lon": -4.42034
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this randomized double-blind placebo-controlled clinical study is to determine whether the dietary intervention with pectins leads to food immunomodulation in non-specific lipid transfer proteins (nsLTP) allergic patients. The main question it aims to answer is if the microbiome is a target of intervention against food allergy through the use of prebiotics such as pectins.Participants will be enrolled to receive a two-month dietary intervention with either two different pectins (citrus or apple pectin) or placebo. Increase in oral tolerance to the peach nsLTP will be measured through a double-blind placebo-controlled food challenge (DBPCFC). Microbiome, proteomic and metabolomic studies will also be performed in blood and stool samples."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Treatment will be blinded to the participants and research team.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 51,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "AC18/00031",
"briefTitle": "Dietary Intervention in Food Allergy",
"nctId": "NCT06386081",
"orgStudyIdInfo": {
"id": "AC18/00031",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Clinical efficacy of pectin dietary intervention in nsLTP allergic patients"
}
],
"secondaryOutcomes": [
{
"measure": "Changes in Pru p 3 (nsLTP of peach) specific IgE production induced by pectin intervention"
},
{
"measure": "Pru p 3-specific maturational changes of dendritics cells induced by pectin intervention"
},
{
"measure": "Pru p 3-specific proliferative response of different lymphocytes cell subpopulations after pectin intervention"
},
{
"measure": "Changes in Pru p 3-specific basophil activation induced by pectin intervention"
},
{
"measure": "Changes induced in the taxonomic diversity of gut microbiota"
},
{
"measure": "Changes in feaces metabolome induced by pectin dietary intervention"
},
{
"measure": "Changes in serum metabolome induced by the pectin dietary intervention"
},
{
"measure": "Epigenomic changes induced by the pectin dietary intervention"
},
{
"measure": "Pectin safety profile"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Values-based Cognitive Behavioral Therapy (V-CBT)"
}
]
},
"conditionsModule": {
"conditions": [
"Whiplash Injuries"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rødovre",
"contacts": [
{
"email": "[email protected]",
"name": "Anders O Aaby, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Specialized Hospital for Polio and Accident Victims",
"geoPoint": {
"lat": 55.68062,
"lon": 12.45373
},
"state": "Capital Region Of Denmark",
"status": "RECRUITING",
"zip": "2610"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to address the critical need for effective interventions by developing and testing an interdisciplinary values-based cognitive behavioral therapy (V-CBT) program for individuals with persistent whiplash. The main question it aims to answer are:* What is the treatment effect of the interdisciplinary values-based cognitive behavioral therapy (V-CBT) program on individuals with persistent whiplash?* What are the temporal relationships between primary and secondary outcome measures in the context of the V-CBT program?Participants will undergo a replicated multiple baselines single-case experimental design (SCED). Twelve participants who meet specific eligibility criteria will be block-randomized to a 1, 2, or 3-week baseline phase, serving as their own controls. The intervention involves an interdisciplinary team delivering a manualized adapted V-CBT program over ten sessions, focusing on psychological and physical rehabilitation. Participants will be required to attend these sessions as part of the treatment protocol. Data collection includes daily online self-reports and comprehensive measurements at pre-treatment, post-treatment, and a three-month follow-up."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "A replicated multiple baselines single-case experimental design with three baseline phases. Baseline randomization into three tiers.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "VALIANT",
"briefTitle": "Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Persistent Whiplash Associated Disorders.",
"nctId": "NCT06386068",
"orgStudyIdInfo": {
"id": "2110041",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Value-based living"
},
{
"measure": "Pain interference"
},
{
"measure": "Value-based living"
},
{
"measure": "Pain interference"
}
],
"secondaryOutcomes": [
{
"measure": "Pain catastrophizing"
},
{
"measure": "Positive affect"
},
{
"measure": "Negative affect"
},
{
"measure": "Stress"
},
{
"measure": "Fatigue"
},
{
"measure": "Pain-related acceptance"
},
{
"measure": "Pain-related self-efficacy"
},
{
"measure": "Pain severity"
},
{
"measure": "Neck Disability"
},
{
"measure": "Depression"
},
{
"measure": "Anxiety"
},
{
"measure": "Stress"
},
{
"measure": "Health-related quality of life"
},
{
"measure": "Pain-related acceptance"
},
{
"measure": "Pain-related self-efficacy"
},
{
"measure": "Sleep quality"
},
{
"measure": "Pain severity"
},
{
"measure": "Self-perceived improvement"
},
{
"measure": "Satisfaction with treatment"
},
{
"measure": "Pain Disability"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Southern Denmark"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-23"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Active exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Physical Inactivity",
"Pollution; Exposure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Buffalo",
"contacts": null,
"country": "United States",
"facility": "University at Buffalo",
"geoPoint": {
"lat": 42.88645,
"lon": -78.87837
},
"state": "New York",
"status": null,
"zip": "14214"
}
]
},
"descriptionModule": {
"briefSummary": "This is a small pilot intervention trial in which we will collect preliminary data to demonstrate the feasibility of an intervention study."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "35 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "PARC",
"briefTitle": "Air Pollution and Physical Activity: A Randomized Controlled Trial",
"nctId": "NCT06386055",
"orgStudyIdInfo": {
"id": "STUDY00007545",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "blood pressure"
}
],
"secondaryOutcomes": [
{
"measure": "Self-report questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "State University of New York at Buffalo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "no intervention, observational study"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rotterdam",
"contacts": null,
"country": "Netherlands",
"facility": "Erasmus MC",
"geoPoint": {
"lat": 51.9225,
"lon": 4.47917
},
"state": "Zuid-Holland",
"status": null,
"zip": "3015CE"
}
]
},
"descriptionModule": {
"briefSummary": "SUMMARY Rationale: Quality of Care registries provide valuable insight in guideline adherence and implementation of guideline recommendations in routine clinical practice.Objective: The overall aim of the project is to study the titration of guideline directed medical therapy (GDMT) according to the European Society of Cardiology (ESC) HF 2021 guideline recommendations for patients with heart failure (HF) reduced ejection fraction (HFrEF), and mildly reduced ejection fraction (HFmrEF).Study design: The current study is a prospective multi-center national quality of care registry (longitudinal) of regular HF care (as given).Study population: The study population consists of patients with heart failure (de novo HF, chronic HF and worsening HF). Study setting is outpatient or inpatient (during admission). Patient sample is set at a minimum of 4000 patients, but can be expanded during the course of the registry project.Participating sites: all hospitals with dedicated HF outpatient clinic in the Netherlands can participate.Data: aggregated dataIntervention: none / noMain study parameters/endpoints: The main parameters of quality of HF care are the adherence to guideline recommendation in terms of percentage (%) drug prescription, percentage (%) target dose (order, speed) and reason not to adhere to the guideline (intolerance, side-effects, maximum tolerated dose). The main endpoints for prognosis are the number of HF related hospitalizations and all-cause mortality during follow-up.Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no risk in participation, no intervention and no active involvement of patients for specific activities in the study. The project is a registration of care as given (standard care) to the participating subject with heart failure."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 4289,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TITRATE-HF",
"briefTitle": "Guideline Implementation and Quality of Care in Patients With Heart Failure: the TITRATE-HF Registry",
"nctId": "NCT06386042",
"orgStudyIdInfo": {
"id": "MEC-2022-0252",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Prescription level (percentage,%) and target dose (percentage, %) of guideline-directed medical therapy for HF"
}
],
"secondaryOutcomes": [
{
"measure": "All-cause mortality"
},
{
"measure": "Hospital admission due to heart failure related event and/or urgent visit with necessity of furosemide iv."
},
{
"measure": "Hospital admission due to non heart failure related event"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Netherlands Heart Institute"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Erasmus Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-02-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-06-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Power Down bedtime manipulation"
}
]
},
"conditionsModule": {
"conditions": [
"Autism",
"Sleep Disturbance"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pittsburgh",
"contacts": [
{
"email": "[email protected]",
"name": "Amy G Hartman, PhD",
"phone": "614-989-6303",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Pittsburgh",
"geoPoint": {
"lat": 40.44062,
"lon": -79.99589
},
"state": "Pennsylvania",
"status": null,
"zip": "15213"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called \"The Power Down\" for autistic youth, ages 6-10. The main questions it aims to answer are:1. Is the Power Down feasible for caregivers to do each night?2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep?"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Pilot, non-blinded intervention trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "10 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol",
"nctId": "NCT06386029",
"orgStudyIdInfo": {
"id": "STUDY24010191",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Recruitment rates of participants through the trial"
},
{
"measure": "Retention rates of participants through the trial"
},
{
"measure": "Caregiver reported acceptability"
}
],
"secondaryOutcomes": [
{
"measure": "Treatment adherence"
},
{
"measure": "Data collection rates- Questionnaires"
},
{
"measure": "Data collection rates- Daily diaries"
},
{
"measure": "Data collection rates- Wearing the actigraphy watch"
},
{
"measure": "Credibility/Expectancy Questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Pittsburgh"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "artificial intelligence-based stethoscope"
}
]
},
"conditionsModule": {
"conditions": [
"Valvular Heart Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Xiaodong Zhuang, PhD",
"phone": "+86 13760755035",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "First Affiliated Hospital, Sun Yat-Sen University",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": "RECRUITING",
"zip": "510000"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to develop a deep learning-based application of heart sounds in the diagnosis of valvular heart disease, which can be used to screen patients with valvular heart disease and promote earlier clinical monitoring and intervention."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 2000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Detection of Valvular Heart Disease Using Artificial Intelligence-based Stethoscope",
"nctId": "NCT06386016",
"orgStudyIdInfo": {
"id": "Stethoscope study",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "valvular heart disease"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Xiao-dong Zhuang"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Psilocybin"
}
]
},
"conditionsModule": {
"conditions": [
"Post Traumatic Stress Disorder",
"PTSD",
"Chronic PTSD"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": null,
"country": "Canada",
"facility": "St. Michael's Hospital, Unity Health Toronto",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD",
"nctId": "NCT06386003",
"orgStudyIdInfo": {
"id": "23-230",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Effect on digital physiological passive data collected through the use of a wearable device"
}
],
"primaryOutcomes": [
{
"measure": "Feasibility and tolerability"
}
],
"secondaryOutcomes": [
{
"measure": "Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score"
},
{
"measure": "Posttraumatic stress disorder Checklist-5 (PCL-5)"
},
{
"measure": "Patient Health Questionnaire-9 (PHQ-9)"
},
{
"measure": "Generalized Anxiety Disorder Scale, 7-item (GAD-7)"
},
{
"measure": "Dissociative Experiences Scale II (DES-II)"
},
{
"measure": "Pittsburgh Sleep Quality Index (PSQI)"
},
{
"measure": "World Health Organization Well-Being Index, 5-item (WHO-5)"
},
{
"measure": "Quality of relationships inventory (QRI)"
},
{
"measure": "Inventory of psychosocial functioning (IPF)"
},
{
"measure": "Posttraumatic Maladaptive Beliefs Scale (PMBS)"
},
{
"measure": "Brief Experiential Avoidance Questionnaire (BEAQ)"
},
{
"measure": "24-items Multidimensional Psychological Flexibility Inventory (MPFI-24)"
},
{
"measure": "Working Alliance Inventory- Short Form (WAI-SF)"
},
{
"measure": "Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)"
},
{
"measure": "Self-Compassion Scale-Short Form (SCS-SF)"
},
{
"measure": "Psychological Insight Questionnaire (PIQ)"
},
{
"measure": "Emotional Breakthrough Inventory (EBI)"
},
{
"measure": "Altered States of Consciousness Rating Scale (ASC)"
},
{
"measure": "Acceptance/Avoidance-Promoting Experiences Questionnaire (APEQ)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Toronto Metropolitan University"
},
{
"name": "University of Ottawa"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Unity Health Toronto"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "UTD1"
}
]
},
"conditionsModule": {
"conditions": [
"Triple Negative Breast Neoplasms"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Changsha",
"contacts": [
{
"email": "[email protected]",
"name": "Quchang Ouyang",
"phone": "8673189762161",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Quchang Ouyang",
"geoPoint": {
"lat": 28.19874,
"lon": 112.97087
},
"state": "Hunan",
"status": "RECRUITING",
"zip": "410083"
}
]
},
"descriptionModule": {
"briefSummary": "This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug.Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 53,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy",
"nctId": "NCT06385990",
"orgStudyIdInfo": {
"id": "2024ks01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "2-year disease-free survival (DFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall Survival (OS)"
},
{
"measure": "Disease Free Survival (DFS)"
},
{
"measure": "Invasive Disease free survival (iDFS)"
},
{
"measure": "Distant Disease-free Survival (DDFS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hunan Cancer Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "lifestyle"
},
{
"name": "sexual habits"
},
{
"name": "medication"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Prostatitis With Chronic Pelvic Pain Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Xi'an",
"contacts": [
{
"email": "[email protected]",
"name": "Qian Deng, Doctor",
"phone": "86-029-85251331",
"phoneExt": "2079",
"role": "CONTACT"
}
],
"country": "China",
"facility": "Shaanxi Provincial People's Hospital",
"geoPoint": {
"lat": 34.25833,
"lon": 108.92861
},
"state": "Shaanxi",
"status": "RECRUITING",
"zip": "710061"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to learn about the risk factors of lifestyle, medication and sexual habits in adult chronic prostatitis / chronic pelvic pain syndrome patients. The main questions it aims to answer are:* Is lifestyle, medication, and sexual habits related to chronic prostatitis / chronic pelvic pain syndrome* Is there any medication available to protect men from chronic prostatitis / chronic pelvic pain syndrome.Participants will:* Independently receive a survey questionnaire on lifestyle, medication, and sexual habits.* Symptomatic individuals will undergo additional prostate fluid examination for diagnosis.Researchers will compare healthy adult males to see if there are differences on lifestyle, medication and sexual habits between the two groups."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Risk Factors for Chronic Prostatitis Patients in Northwest China",
"nctId": "NCT06385977",
"orgStudyIdInfo": {
"id": "ShaanxiPPH",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Odds Ratio"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shaanxi Provincial People's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2016-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SHR-4597"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Subjects",
"Asthmatic Patients"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The primary objective of this randomized, double-blind, single/multiple ascending dose, placebo-controlled Phase I clinical trial was to evaluate the safety and tolerability of SHR-4597 in healthy subjects and asthmatic patients. The study consists of two parts: Part 1 involves single ascending inhalation dose in healthy subjects; Part 2 involves multiple ascending inhalation dose in asthmatic patients, further divided into Part 2A: multiple ascending inhalation dose in mild to moderate asthmatic patients, and Part 2B: multiple ascending inhalation dose in moderate to severe asthmatic patients. Subsequent lung pharmacokinetic studies of SHR-4597 inhalation will be conducted based on patients' PKPD data."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-4597 Inhalation in Healthy Subjects and Asthmatic Patients",
"nctId": "NCT06385964",
"orgStudyIdInfo": {
"id": "SHR-4597-101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence and severity of inhalant adverse events after 4 days of single inhalation of SHR4597 in healthy subjects"
},
{
"measure": "Incidence and severity of inhalant adverse events after 16 days of multiple inhalation of SHR4597 in asthmatic patients,"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Guangdong Hengrui Pharmaceutical Co., Ltd"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Procedure for patients"
},
{
"name": "Procedure for healthy controls"
}
]
},
"conditionsModule": {
"conditions": [
"Mild Cognitive Impairment",
"Alzheimer Disease",
"Healthy Aging"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ghent",
"contacts": [
{
"email": "[email protected]",
"name": "Tineke Van Vrekhem",
"phone": "093326483",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "University Hospital Gent",
"geoPoint": {
"lat": 51.05,
"lon": 3.71667
},
"state": "East-Flanders",
"status": "RECRUITING",
"zip": "9000"
}
]
},
"descriptionModule": {
"briefSummary": "Alzheimer's Disease (AD) is the most common form of dementia and may contribute to 60-70 % of all cases. An early, accurate diagnosis of AD will become increasingly important with disease-modifying therapies. Different types of fluid and neuroimaging biomarkers are available for the early detection of AD. However, implementation of routine use of these biomarkers in clinical settings is held back due to the risk of overdiagnosis, increased cost and invasiveness of the assessment method. Therefore, novel biomarkers are needed beyond the amyloid and tau pathologies for the early diagnosis of AD. Neuropsychological paper and pencil tests can detect AD and discriminate between different clinical stages. Since medial temporal lobe structures, including the hippocampus and entorhinal cortex (EC), are involved in spatial navigation and degenerate in the earliest stages of AD, spatial navigation can be considered as an early cognitive biomarker of the disease. Nonetheless, the measurement of spatial navigation needs further improvement since the current paper and pencil tests lack ecological validity. Therefore, the test environment should be set up in immersive Virtual Reality (iVR). Dr. Andrea Castegnaro (Space and Memory Lab of University College of London) developed the Allocentric Spatial Update Task (ALLO task), which is an iVR task measuring egocentric and allocentric spatial abilities.Therefore, the main objective of this study is to evaluate whether allocentric and egocentric spatial navigation, measured by the ALLO iVR task can be considered a cognitive biomarker for the early detection of AD. In addition, the investigators want to report on the neuronal correlates of both spatial navigation strategies.Through the Department of Neurology of the University Hospital of Ghent, which has a large cognitive disorders clinic, patients with mild cognitive impairment and mild Alzheimer's dementia will be recruited. Participants will undergo standard clinical assessment, including a neuropsychological examination, Magnetic Resonance Imaging, a 18F-fluorodeoxyglucose PET and a Lumbar Puncture. In addition, participants will also be asked to undergo Tau PET imaging, Amyloid PET imaging and complete the ALLO iVR task. Healthy controls will also be recruited and have to undergo the same investigations, except for the amyloid PET and lumbar puncture."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 160,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ALLO-task",
"briefTitle": "Spatial Navigation for the Early Detection of Alzheimer's Disease.",
"nctId": "NCT06385951",
"orgStudyIdInfo": {
"id": "ONZ-2023-0323",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Spatial navigation abilities"
}
],
"secondaryOutcomes": [
{
"measure": "Medial Temporal Lobe atrophy"
},
{
"measure": "Amount and spreading of amyloid in the brain"
},
{
"measure": "Amount and spreading of tau in the brain"
},
{
"measure": "Decreases in cerebral glucose metabolism in the brain"
},
{
"measure": "Cognitive functioning"
},
{
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},
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]
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],
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"measure": "Case-control comparison of quantitative vibro-acoustic ultrasound measurements between children with rickets and control subjects"
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]
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},
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}
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],
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"measure": "Objective response rate (ORR) in phase 2 part"
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{
"measure": "Time to maximum blood concentration (Tmax)"
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{
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}
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}
}
} | false | null |
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},
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"measure": "Changes in HbA1c levels after 12 months treatment"
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{
"measure": "percentage of patients who reached the HbA1c target of equal to or below 7%"
}
],
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{
"measure": "The effect of education on the HbA1c changes"
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{
"measure": "The effect of depression on the HbA1c changes"
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{
"measure": "The effect of the level of physical activity on the HbA1c changes"
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{
"measure": "The effect of weight loss on the HbA1c changes"
}
]
},
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"date": "2021-08-01"
},
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}
}
} | false | null |
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},
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"name": "Marsha Treadwell, PhD",
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{
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],
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],
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},
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{
"measure": "Affiliation with a Sickle cell disease (SCD)-specific care with SCD specialist"
}
],
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{
"measure": "Scale Out to Other SCD Centers - Implementation in at least 2 other SCD Center study sites"
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]
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},
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}
} | false | null |
{
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{
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{
"name": "Apatinib"
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{
"name": "S-1"
}
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},
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},
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"id": "2024-SR-233",
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"measure": "Pathological Complete Response Rate (pCR)"
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"measure": "Major Pathological Response rate (MPR)"
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{
"measure": "R0 Resection rate"
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{
"measure": "Disease-Free Survival (DFS）"
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{
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}
}
} | false | null |
{
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]
},
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"descriptionModule": {
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},
"identificationModule": {
"acronym": "PM-EBS-BS",
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"id": "GTMGS0423",
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"measure": "early biliary stasis"
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{
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}
} | false | null |
{
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"name": "Zoladex"
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{
"name": "LY01005"
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]
},
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]
},
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{
"city": "Xiamen",
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{
"email": "[email protected]",
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"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Xiamen University",
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},
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}
]
},
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},
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},
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},
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]
},
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},
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],
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},
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},
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},
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},
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},
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"date": "2024-04-26"
}
}
} | false | null |
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"interventions": [
{
"name": "Morning aerobic exercise"
},
{
"name": "Evening aerobic exercise"
}
]
},
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"conditions": [
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]
},
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"locations": null
},
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},
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]
},
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},
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},
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],
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},
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"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
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"id": "LY2014-041-A",
"link": null,
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},
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},
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"measure": "left ventricle ejection fraction"
}
],
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{
"measure": "Oxygen consumption"
},
{
"measure": "Endothelial Function"
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{
"measure": "Skeletal muscle and fat mass"
},
{
"measure": "Cardiac structure"
},
{
"measure": "One year major Adverse Cardiovascular Events"
},
{
"measure": "VE/VCO2-SLOPE"
},
{
"measure": "Flow-mediated dilation"
},
{
"measure": "glucose"
},
{
"measure": "Blood lipid"
},
{
"measure": "N-terminal pro-BNP"
}
]
},
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}
},
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},
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},
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}
}
} | false | null |
{
"armsInterventionsModule": {
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{
"name": "Grippol Quadrivalent"
},
{
"name": "Grippol Plus"
}
]
},
"conditionsModule": {
"conditions": [
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"Influenza A",
"Influenza, Human",
"Influenza Type B",
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"Influenza A H3N2",
"Influenza A H1N1",
"Influenza Epidemic",
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"Acute Respiratory Infection",
"Vaccine Reaction"
]
},
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{
"city": "Ekaterinburg",
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"country": "Russian Federation",
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},
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},
{
"city": "Moscow",
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"geoPoint": {
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},
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},
{
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{
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},
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},
{
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"contacts": null,
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"facility": "Limited Liability Company \"Clinic USI 4D\"",
"geoPoint": {
"lat": 44.04861,
"lon": 43.05944
},
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},
{
"city": "Saint Petersburg",
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},
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},
{
"city": "Saint Petersburg",
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"facility": "St. Petersburg State Budgetary Health Institution \"Children's City Polyclinic No. 45 of the Nevsky District\"",
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},
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{
"city": "Saint Petersburg",
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"facility": "Limited Liability Company \" Energiia Zdoroviya\"",
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},
"state": null,
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},
{
"city": "Saint Petersburg",
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},
{
"city": "Saint Petersburg",
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{
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},
{
"city": "Samara",
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"geoPoint": {
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"lon": 50.15
},
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},
{
"city": "Saratov",
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"lat": 51.54056,
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},
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},
{
"city": "Tyumen",
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"facility": "Federal State Budgetary Educational Institution of Higher Education \"Tyumen State Medical University\" of the Ministry of Healthcare of the Russian Federation",
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"descriptionModule": {
"briefSummary": "The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the \"proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination\"."
},
"designModule": {
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},
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},
"enrollmentInfo": {
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},
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "5 Years",
"minimumAge": "6 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus",
"nctId": "NCT06385821",
"orgStudyIdInfo": {
"id": "GriQv-ch-III-22",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To prove non-inferior immunogenicity of the Grippol Quadrivalent vaccine when compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three matching strains of the compared vaccines"
}
],
"secondaryOutcomes": [
{
"measure": "Geometric mean antibody titers"
},
{
"measure": "Proportion of those vaccinated with seroconversion and geometric mean titer"
},
{
"measure": "Multiplicity of the increase in the geometric mean titer"
},
{
"measure": "Seroprotection"
},
{
"measure": "Incidence of influenza and acute respiratory infections (ARI)"
},
{
"measure": "The severity and duration of registered cases of influenza and acute respiratory infections (ARI), the presence of complications"
},
{
"measure": "To assess the reactogenicity of the vaccine Grippol Quadrivalent and the vaccine Grippol plus"
},
{
"measure": "Frequency and nature of SAEs"
},
{
"measure": "Frequency and nature of medically attended AEs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "NPO Petrovax"
}
},
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"date": "2023-10-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
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"date": "2023-06-15"
},
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"startDateStruct": {
"date": "2022-09-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
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"interventions": [
{
"name": "MTBF regimen"
}
]
},
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"conditions": [
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"Refractory Acute Myeloid Leukemia",
"Conditioning",
"Hematopoietic Stem Cell Transplantation"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia. The secondary purpose of the study was to observe the safety of MTBF regimen in these patients."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "The relapsed or refractory acute myeloid leukemia patients will pretreated with the MTBF regimen prior to salvageable allogeneic hematopoietic stem cells. The one-year recurrence-free survival after transplantation of these patients and the safty of the MTBF regimen will be studied.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 37,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R/R AML",
"nctId": "NCT06385808",
"orgStudyIdInfo": {
"id": "XJTU1AF-CRF-2023-XK014",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "aGVHD"
}
],
"primaryOutcomes": [
{
"measure": "Recurrence rate"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence and Severity of non-hematological adverse events (NCI CTCAE v5.0)"
},
{
"measure": "Neutrophil recovery time"
},
{
"measure": "Platelet recovery time"
},
{
"measure": "OS"
},
{
"measure": "PFS"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "First Affiliated Hospital Xi'an Jiaotong University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "NOE-115"
}
]
},
"conditionsModule": {
"conditions": [
"Menopause Syndrome",
"Menopause",
"Hot Flashes"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot flashes) due to menopause in women."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "45 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause",
"nctId": "NCT06385795",
"orgStudyIdInfo": {
"id": "NOE-PMM-201",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Withdrawals Due to Adverse Events While on NOE-115 for Any Reason"
}
],
"secondaryOutcomes": [
{
"measure": "Number of Participants Who Experience at Least One or More Adverse Event and the Severity of the Adverse Events (AEs)"
},
{
"measure": "Weekly Mean Change in the Severity of Hot Flashes from Baseline to Week 4"
},
{
"measure": "Weekly Mean Change in the Frequency (any severity) of Hot Flashes from Baseline to Week 4"
},
{
"measure": "Effect of NOE-115 as Assessed by Clinical Global Impression of Severity (CGI-S) from Baseline to Week 4"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Noema Pharma AG"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Antarctic environment"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Rate Variability"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": null,
"country": "China",
"facility": "Shanghai Tenth People's Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "200079"
}
]
},
"descriptionModule": {
"briefSummary": "Extreme changes in the Antarctic environment can cause emotional and autonomic dysfunction. In this study, volunteers from the Antarctica stations in China provided scale scores and heart rate variability (HRV) data, which were used to assess the autonomic nervous system. Enroll twenty-two members from Zhongshan Station and the Great Wall Station who are overwintering. Using the Generalized Anxiety Disorder (GAD-7) scale, the Patient Health Questionnaire-9 (PHQ-9) scale, and the SF-36 quality of life scale to evaluate the individual's general physical and mental health. Analyze HRV and other associated parameters."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 22,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "MALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Exploring HRV in Antarctic Overwintering Members of Asia",
"nctId": "NCT06385782",
"orgStudyIdInfo": {
"id": "20dz1207200",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "changes in HRV"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ya-Wei Xu"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transcutaneous tibial nerve stimulation (TTNS)"
},
{
"name": "Sham Transcutaneous tibial nerve stimulation (TTNS)"
}
]
},
"conditionsModule": {
"conditions": [
"Urinary Bladder, Overactive"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Denizli",
"contacts": null,
"country": "Turkey",
"facility": "Pamukkale University",
"geoPoint": {
"lat": 37.77417,
"lon": 29.0875
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The investigators conducted a prospective, randomized, double-blind, placebo-controlled study based on the placebo technique to evaluate the efficacy of TTNS versus placebo in patients with OAB after stroke.The main questions aimed to be answered are:What are the effects of Trans Tibial Nerve Stimulation (TTNS) on incontinence-related clinical parameters and quality of life in patients with overactive bladder (OAB) after stroke compared to the placebo group? Participants (n:22) with post-stroke AAM who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive TTNS (n:11) and the second group will receive placebo TTNS (n:11). Measurements will be performed twice in total, before treatment and at the end of treatment (4th week)."
},
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},
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]
},
"identificationModule": {
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"briefTitle": "Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke",
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"id": "PamukkaleU.ftr-NYıldız-3",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Decreased frequency of increased voiding"
}
],
"secondaryOutcomes": [
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"measure": "Frequency of voiding"
},
{
"measure": "The Quality of Life"
},
{
"measure": "Barthel Index for Activities of Daily Living (ADL)"
},
{
"measure": "The Overactive Bladder Symptom Score (OABSS)"
},
{
"measure": "Treatment Satisfaction Level"
},
{
"measure": "Cystometric value"
}
]
},
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"class": "OTHER",
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}
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"date": "2026-02-28"
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},
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"date": "2024-04-22"
},
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"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Amobarbital"
},
{
"name": "Propofol"
}
]
},
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"conditions": [
"Amobarbital Sodium",
"Hemodynamics Instability"
]
},
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"briefSummary": "At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery.The main questions it aims to answer are:* whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients;* whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction.Participants will:* Induction of anesthesia with the experimental drug or placebo；* 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels；* To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded."
},
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},
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"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
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"maximumAge": "60 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
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"briefTitle": "Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions",
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"id": "TJ-IRB202403020",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mean arterial pressure (MAP) during Induction of anesthesia"
}
],
"secondaryOutcomes": [
{
"measure": "MAP at different time points"
},
{
"measure": "Incidence of postoperative nausea and vomiting (ponv)"
}
]
},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Tongji Hospital"
}
},
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"date": "2026-05-01"
},
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},
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"date": "2026-05-01"
},
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"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Neuromuscular Training-based Exercise Program"
},
{
"name": "''Thrower's Ten'' Exercise Program"
}
]
},
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"conditions": [
"Pain, Shoulder",
"Sports Physical Therapy"
]
},
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"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Yeditepe University",
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"lat": 41.01384,
"lon": 28.94966
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"state": null,
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}
]
},
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},
"designModule": {
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},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
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},
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"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effectiveness of Neuromuscular Training-Based Exercise Program",
"nctId": "NCT06385743",
"orgStudyIdInfo": {
"id": "yeditepe15",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain Assessment"
},
{
"measure": "Disabilities of the Arm, Shoulder and Hand (DASH)"
}
],
"secondaryOutcomes": [
{
"measure": "Tampa Kinesiophobia Scale"
},
{
"measure": "Hylyght Injury Prevention and Return to the Sports Screening Program ("
},
{
"measure": "Y Balance Test- Upper Quarter"
},
{
"measure": "Closed Kinetic Chain Extremity Stability Test"
},
{
"measure": "Single Arm Seated Shot Put Test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Yeditepe University"
}
},
"statusModule": {
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"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-14"
},
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"startDateStruct": {
"date": "2023-04-17"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
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"interventions": [
{
"name": "neoadjuvant anti-PD-1"
},
{
"name": "neoadjuvant anti-PD-1 with LDRT"
}
]
},
"conditionsModule": {
"conditions": [
"Esophageal Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": null,
"country": "China",
"facility": "Shanghai Chest Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "200030"
}
]
},
"descriptionModule": {
"briefSummary": "The investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of neoadjuvant PD-1 blockade monotherapy with toripalimab in elderly patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC)."
},
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},
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},
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},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
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"sex": "ALL",
"stdAges": [
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]
},
"identificationModule": {
"acronym": "BLESS",
"briefTitle": "Neoadjuvant PD-1 Blockade for Elderly Esophageal Squamous Cell Carcinoma (BLESS)",
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"id": "SCE2401",
"link": null,
"type": null
},
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},
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{
"measure": "MPR rate"
}
],
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{
"measure": "pCR rate"
},
{
"measure": "Adverse events and treatment-related adverse events"
},
{
"measure": "R0 resection rate"
},
{
"measure": "Objective Response rate"
},
{
"measure": "Event-free survival (EFS)"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "Correlation between potential biomarkers and tumor response"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shanghai Chest Hospital"
}
},
"statusModule": {
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"date": "2027-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
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"date": "2025-05"
},
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"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "chemo-radiation"
}
]
},
"conditionsModule": {
"conditions": [
"Esophagus Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Jing Xu, MD",
"phone": "0086-0571-87783521",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The Second Affiliated Hospital of Zhejiang University School of Medicine",
"geoPoint": {
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},
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"status": "RECRUITING",
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},
{
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"contacts": [
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"email": "[email protected]",
"name": "Jing Xu",
"phone": "0086-0571-87783521",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The Second Affiliated Hospital of Zhejiang University, School of Medicine",
"geoPoint": {
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"lon": 120.16142
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection."
},
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},
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},
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},
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"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ESCORT",
"briefTitle": "Multicenter Cohort Study of ESD and Chemo-radiotherapy for High-risk Early-stage Esophageal Cancer",
"nctId": "NCT06385717",
"orgStudyIdInfo": {
"id": "ZhejiangU",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Incidence of toxic events"
}
],
"secondaryOutcomes": [
{
"measure": "3-year overall survival"
},
{
"measure": "3-year local-regional recurrence free survival"
}
]
},
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"collaborators": null,
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"class": "OTHER",
"name": "Second Affiliated Hospital, School of Medicine, Zhejiang University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
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"date": "2026-01-31"
},
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"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "DMR Procedure"
}
]
},
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"conditions": [
"Diabetes Mellitus, Type 2"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of this study is to demonstrate the effects of duodenal mucosal resurfacing (DMR) on intestinal barrier function and gut microbiota when treating uncontrolled type 2 diabetes. Subjects who underwent DMR and those who did not were enrolled, and potential differences were identified by analyzing urine and fecal samples through microbiomic analysis and High Performance Liquid Chromatography（HPLC）, combined with changes in clinical data."
},
"designModule": {
"designInfo": {
"allocation": "NA",
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"interventionModelDescription": null,
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"masking": "NONE",
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"whoMasked": null
},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
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"maximumAge": "65 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DMR-IBF-GM",
"briefTitle": "Research on Changes in Intestinal Barrier Function and Gut Microbiome in Patients With Type 2 Diabetes After Duodenal Mucosal Resurfacing (DMR)",
"nctId": "NCT06385704",
"orgStudyIdInfo": {
"id": "DMRIBFGM0420",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Microbiome Analysis"
},
{
"measure": "High Performance Liquid Chromatography"
}
],
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},
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"collaborators": [
{
"name": "China-Japan Friendship Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Wang Siqi"
}
},
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"date": "2025-12-01"
},
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"date": "2024-04-26"
},
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"date": "2025-06-01"
},
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"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "myDIET software tool"
}
]
},
"conditionsModule": {
"conditions": [
"Gastric Cancer",
"Oesogastric Junction Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lyon",
"contacts": [
{
"email": "[email protected]",
"name": "Pamela Funk-Debleds, MD",
"phone": "0469856020",
"phoneExt": "+33",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Clélia Coutzac, MD",
"phone": "0469856020",
"phoneExt": "+33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre Léon Berard",
"geoPoint": {
"lat": 45.74848,
"lon": 4.84669
},
"state": null,
"status": null,
"zip": "69008"
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective, single-center, single-arm Phase II study evaluating the efficacy of the myDIET software tool in the nutritional management of patients with localized and resectable esogastric junction cancer."
},
"designModule": {
"designInfo": {
"allocation": "NA",
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},
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},
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"count": 60,
"type": "ESTIMATED"
},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MyDIET",
"briefTitle": "Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.",
"nctId": "NCT06385691",
"orgStudyIdInfo": {
"id": "ET22-145",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Proportion of patients starting adjuvant chemotherapy within 2 months"
}
],
"secondaryOutcomes": [
{
"measure": "Adherence to the tool"
},
{
"measure": "Number of supportive care and emergency consultations initiated by the caregiver"
},
{
"measure": "Proportion of patients with malnutrition"
},
{
"measure": "Evolution of body composition in L3 section (volumes)"
},
{
"measure": "Evolution of body composition in L3 section (indexes)"
},
{
"measure": "Evolution of resting energy expenditure"
},
{
"measure": "Proportion of patient covering theoretical nutritional requirement >= 30kcal/kg/day"
},
{
"measure": "Comparison between theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry"
},
{
"measure": "Weight changes"
},
{
"measure": "Brachial circumference changes"
},
{
"measure": "Triceps skin fold changes"
},
{
"measure": "Initiation time for post-operative chemotherapy"
},
{
"measure": "Proportion of patient with incomplete scheme of pre operative chemotherapy"
},
{
"measure": "Proportion of patient with incomplete scheme of post operative chemotherapy"
},
{
"measure": "Proportion of patients with severe post operative complication"
},
{
"measure": "Tolerance to perioperative chemotherapy"
},
{
"measure": "Changes in food intake"
},
{
"measure": "Changes in SEFI (Easy Food Intake Score)"
},
{
"measure": "Measurement of quality of life"
},
{
"measure": "Average lengh of hospital stay"
},
{
"measure": "Recurrence free survival (RFS)"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "Adherence to the physical activity program"
},
{
"measure": "Physical activity levels"
},
{
"measure": "Assessment of muscular function by the 6-min walk test"
},
{
"measure": "Assessment of muscular function by muscular strength"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Leon Berard"
}
},
"statusModule": {
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"date": "2026-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2026-06-30"
},
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"startDateStruct": {
"date": "2024-04-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "HRS-4642"
},
{
"name": "Adebrelimab"
},
{
"name": "SHR-A1921"
},
{
"name": "Pemetrexed Disodium for Injection、Cisplatin Injection、Carboplatin for Injection"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Caicun Zhou, Doctor",
"phone": "13301825532",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Shanghai East Hospital",
"geoPoint": {
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"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "200120"
}
]
},
"descriptionModule": {
"briefSummary": "The study is being conducted to evaluate the safety, tolerability, and efficacy of HRS-4642 in combination with antitumor medicine in patients with advanced solid tumors harboring KRAS G12D mutation."
},
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"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation",
"nctId": "NCT06385678",
"orgStudyIdInfo": {
"id": "HRS-4642-201",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Phase IB: Safety endpoints: adverse events (AEs)."
},
{
"measure": "Phase IB： Maximum tolerated dose (MTD)"
},
{
"measure": "Phase IB：Recommended phase 2 dose (RP2D)"
},
{
"measure": "Phase II: Overall response rate (ORR)."
}
],
"secondaryOutcomes": [
{
"measure": "Efficacy endpoints: Overall response rate (ORR)."
},
{
"measure": "Efficacy endpoints: Duration of response (DoR)."
},
{
"measure": "Efficacy endpoints: Disease control rate (DCR)."
},
{
"measure": "Efficacy endpoints: Progression free survival (PFS)."
},
{
"measure": "Efficacy endpoints: overall survival (OS)."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Jiangsu HengRui Medicine Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Graded companionship"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wuhan",
"contacts": [
{
"email": null,
"name": "Peng Xin, postgraduate",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
},
"state": null,
"status": "RECRUITING",
"zip": "430022"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn about companionship needs in breast cancer patients who are pathologically or cytologically diagnosed as cancer, are alive with the tumor, and have TNM clinical stage IV. The main questions it aims to answer are:1. Patients with advanced breast cancer need family companionship2. Analyze and study the reasons and factors that affect the physical and mental impact of effective family companionship on patients with advanced breast cancer Participants will be divided into a companion group and a non-accompaniment group. Patients in the companion group are given graded companion intervention methods. A comparison group: Researchers will compare a non-accompaniment group to see if the physical and mental impact of companionship on patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 304,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "72 Years",
"minimumAge": "21 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Appropriate Family Companionship on the Physical and Mental Health of Patients With Advanced Breast Cancer",
"nctId": "NCT06385665",
"orgStudyIdInfo": {
"id": "Xin Peng",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change from Baseline meatal state on GAD-7 at Week 48."
},
{
"measure": "Change from Baseline physical state on kps at Week 48."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Xin Peng"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "68Ga-NB381"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Myeloma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Ronghui Yu, Master",
"phone": "+8613466379791",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Lei Kang, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "TIANYAO Wang, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Yongkang Qiu, Master",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Zhenghao Tong, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "China",
"facility": "Peking University First Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100000"
}
]
},
"descriptionModule": {
"briefSummary": "Multiple myeloma (MM) predominantly affects the elderly, often presenting insidiously and with a rising incidence rate. Current diagnostic methods primarily rely on invasive bone marrow biopsies, which can lead to false-negative results if the biopsy site is improperly chosen. CD38 is significantly overexpressed on the surface of malignant plasma cells in MM, making it a characteristic tumor biomarker for this disease.Addressing the limitations in specificity and sensitivity of traditional PET imaging agents, this project is dedicated to developing a new type of nanobody PET/CT imaging probe, 68Ga-NB381, which possesses high affinity and targets CD38. This probe, which is an intellectual property of our institution, aims to enhance the accuracy and specificity of early MM diagnosis. In terms of clinical evaluation, the project will implement a comprehensive assessment process including case selection, collection of baseline information, high-precision imaging, expert-level image interpretation, and follow-up studies, comparing directly with traditional 18F-FDG imaging to thoroughly verify the specificity and safety of 68Ga-NB381. This lays the groundwork for the clinical translation of this radiopharmaceutical in China. Furthermore, the project contributes to formulating more effective precision treatment plans based on CD38 expression levels and provides evidence for monitoring the therapeutic effects of daratumumab, a drug also targeting CD38. This makes the project of significant academic value and clinical importance, thus promoting the development of personalized treatment strategies."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "In this sequential assignment clinical trial, we aim to evaluate and compare the diagnostic performance of two PET imaging agents, 68Ga-NB381 and 18F-FDG, in patients diagnosed with multiple myeloma (MM). The study will enroll MM patients who meet the inclusion criteria and are scheduled for routine diagnostic imaging.Each participant will undergo PET imaging with 18F-FDG first, followed by a second PET scan using 68Ga-NB381 (or reversed). To minimize potential interference between the two imaging sessions and ensure patient safety, a minimum interval of one day will be maintained between the two scans, with all imaging completed within one week. This sequential imaging approach allows for direct comparison of the imaging agents in the same patient, thus controlling for inter-patient variability and providing a more accurate assessment of the relative merits of each imaging agent in the same metabolic and pathological condition.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "All PET/CT images are jointly interpreted by at least two imaging and nuclear medicine physicians, each with several years of diagnostic experience and at least at the attending physician level. They compare and record the number of lesions detected and the SUVs (Standard Uptake Values) for both 18F-FDG and 68Ga-NB381 PET/CT scans. After consultation, they provide a unified diagnostic opinion.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "PET Imaging Study of 68Ga-NB381 in Multiple Myeloma",
"nctId": "NCT06385652",
"orgStudyIdInfo": {
"id": "PekingUFH-MM-NB381",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Specificity and Binding Efficiency of 68Ga-NB381 in CD38 Positive Tumors"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Peking University First Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Probiotic"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Adult"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jakarta",
"contacts": [
{
"email": "[email protected]",
"name": "Danang A. Yunaidi, MD",
"phone": "217515932",
"phoneExt": "+62",
"role": "CONTACT"
}
],
"country": "Indonesia",
"facility": "[email protected]",
"geoPoint": {
"lat": -6.21462,
"lon": 106.84513
},
"state": "Pusat",
"status": "RECRUITING",
"zip": "10430"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive environment and homeostasis of gut microbiota."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Probiotic Products for Digestive Health",
"nctId": "NCT06385639",
"orgStudyIdInfo": {
"id": "WK2024005",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Intestinal health"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Wecare Probiotics Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-25"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Raspberry leaf tea"
}
]
},
"conditionsModule": {
"conditions": [
"Type II Diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Reading",
"contacts": null,
"country": "United Kingdom",
"facility": "Hugh Sinclair Unit of Human Nutrition, University of Reading",
"geoPoint": {
"lat": 51.45625,
"lon": -0.97113
},
"state": "Berkshire",
"status": "RECRUITING",
"zip": "RG6 5SG"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the present clinical trial is to assess how raspberry leaf polyphenols impact on postprandial glucose and insulin levels in healthy individuals consuming sucrose.The questions the project will address:* Do raspberry leaf polyphenols lower sucrose-induced increases in plasma glucose in humans?* Do these polyphenols mediate these effects by inhibiting digestion of sucrose or the absorption of glucose. 20 healthy adults will be recruited between the ages of 18-65 years who are non-smokers and not taking certain types of medication (e.g., drugs from a GP for high blood pressure, high blood fats, inflammatory conditions, and depression) or dietary supplements (e.g., cholesterol-lowering spreads, fish oil, probiotics, prebiotics, and natural laxatives), antibiotics in the last three months or if they used any drugs or supplements that could affect their blood glucose or lipid metabolism. No abnormal results for liver function tests, renal function tests, and lipid profile tests. If they have food allergies or consume more than 14 units of alcohol per week (i.e., to help they calculate a alcohol intake, one standard glass of wine (175 ml) or one pint of regular lager is equivalent to just over two units of alcohol), frequently travel for work or are participating in another intervention study, they will not be able to participate. Women who are pregnant or lactating or planning a pregnancy in the next six months will also not be able to take part, not use herbal medicines for at least the previous three months, not be on a weight loss program six months before screening, not involved in clinical trials six months before the screening, and not having severe cardiac, hepatic, or renal function impairment. Not Sufferers of chronic illnesses, not Individuals with food allergies, not people with coeliac disease.They will be asked to attend a four-study visit after an eight-hour overnight fast. Volunteers will be asked to consume 50 g of carbohydrate powder (sucrose and glucose) with or without 10 g of raspberry leaf tea, which will be dissolved in 300 mL of warm water during four visits (every month). Blood samples will be taken at intervals for a period of two hours after the consumption of raspberry leaf or control. Blood glucose and insulin levels will be tested 15 minutes before, at 15,30,60,90, and 120 minutes after carbohydrate intake."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Volunteers will be asked to consume 50 g of carbohydrate powder (sucrose and glucose) with or without 10 g of raspberry leaf tea, which will be dissolved in 300 mL of warm water during four visits (every month).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RLT",
"briefTitle": "The Effects of Raspberry Leaf Tea on Blood Glucose Control",
"nctId": "NCT06385626",
"orgStudyIdInfo": {
"id": "UREC: 23_15-Raspberry Leaf Tea",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Blood Glucose"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Reading"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-23"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-23"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-18"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mobile-based stoma care education group"
}
]
},
"conditionsModule": {
"conditions": [
"Intestinal Stoma Site Hemorrhage",
"Intestinal Stoma Leakage",
"Life Style, Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Erzurum",
"contacts": [
{
"email": "[email protected]",
"name": "Nilgün Söylemez, PhD Student",
"phone": "+905439790424",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Ataturk University Faculty of Nursing",
"geoPoint": {
"lat": 39.90861,
"lon": 41.27694
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Stomas are most commonly used in the gastrointestinal tract as ileostomy or colostomy. Although colorectal cancers are the most important factor causing intestinal stoma opening, intestinal ostomies are also used in cases such as congenital anomalies, obstructive or inflammatory bowel diseases, traumas requiring surgery, large defects caused by colorectal injuries as well as sigmoid colon volvulus and ischemic colitis. In stoma surgery performed to increase the duration and quality of life of individuals, the patient's compliance with the stoma and awareness of possible complications are important. Conditions such as peristomal skin problems, noisy bowel movements, stool leakage and pain make it difficult to adapt to the stoma.In addition, despite all the advances in stoma care products and surgical techniques, individuals are faced with stoma complications. Therefore, individuals with stoma should be closely monitored for complications. Inappropriately selected stoma site or bag/adapter system, lack of knowledge and skills related to stoma care can be listed among the possible causes of complications. Complications such as edema, bleeding, ischemia and mucocutaneous separation may develop in the first days after stoma surgery. In studies evaluating patients in terms of stoma compliance and complications in the literature, it has been observed that mobile-based trainings given to patients increase their stoma compliance and reduce the incidence of complications. With the mobile-based training planned to be used in the study, it is thought to contribute to the ability of individuals to perform stoma care independently. With the decrease in peristomal skin lesions and stoma complications, it is predicted that the quality of life of patients with stoma will increase, self-care competence will be formed, and health expenditures and therefore national health expenditures will decrease. It is thought that this mobile training application will not only provide support to patients with stoma but also guide healthcare professionals. It will also contribute to closing the shortage of stoma and wound care nurses in hospitals."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Groups will be divided into control and intervention. People in the group will be randomly assigned in a simple randomized manner.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Individuals assigned to controls and interventions will not know which group they are in.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 62,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Mobile-Based Education on Self-Care, Quality of Life and Complications in Patients With Intestinal Stoma",
"nctId": "NCT06385613",
"orgStudyIdInfo": {
"id": "TDK-2024-13377",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Adaptation of Quality Life Scale"
},
{
"measure": "Ostomy Self-Care Index"
},
{
"measure": "Pittman Ostomy Complication Severity Index"
},
{
"measure": "Peristomal Skin Tool"
},
{
"measure": "Ostomy Adjustment Inventory-23"
},
{
"measure": "Computer System Usability Questionnaire"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ataturk University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Labetalol"
},
{
"name": "Phentolamine"
}
]
},
"conditionsModule": {
"conditions": [
"Severe Pre-eclampsia"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The only effective treatment of severe preeclampsia is delivery of the fetus but immediate antihypertensive treatment is given to stabilize the patient and prevent further complications. All antihypertensive medication can potentially cross the placenta. At this time, there are no randomized control trials to base a recommendation for the use of one antihypertensive agent over another. However, certain medications are effective in lowering blood pressure with an acceptable safety profile in pregnancy. The choice of therapy depends on the acuity and severity of hypertension"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Intravenous Labetalol vs Phentolamine for the Management of Severe Preeclampsia.",
"nctId": "NCT06385600",
"orgStudyIdInfo": {
"id": "severe preeclampsia",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the effect of Labetalol and Phentolamine on MCA flow velocity by transcranial Doppler monitoring."
}
],
"secondaryOutcomes": [
{
"measure": "The effect of labetalol and phentolamine on blood pressure of the patients"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oleena"
}
]
},
"conditionsModule": {
"conditions": [
"Head and Neck Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to assess the satisfaction and usability of an interactive and patient-centered mobile application (app), Oleena™, designed to assist head and neck cancer patients undergoing chemoradiation in managing common and distressing symptoms in real-time, as well as to assess the satisfaction and usability of the related HCP web portal. Additional secondary usage and clinical endpoints that would be used to assess intervention efficacy in future trials will be collected."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SYMTECH01",
"briefTitle": "Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients",
"nctId": "NCT06385587",
"orgStudyIdInfo": {
"id": "ADH-OL-Study-01-23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Symptom burden will be measured using the NIH PRO-CTCAE measurement system, which includes validated scales for individual toxicities"
},
{
"measure": "Quality of life will be measured using the previously validated FACT-G scale"
},
{
"measure": "Treatment adherence"
},
{
"measure": "Health-economic outcome"
},
{
"measure": "Complaints, alleged deficiencies or malfunctions of the device reported"
}
],
"primaryOutcomes": [
{
"measure": "Users' satisfaction"
}
],
"secondaryOutcomes": [
{
"measure": "Feasibility of the technology enabled symptom management solution"
},
{
"measure": "Usability of the technology enabled symptom management solution"
},
{
"measure": "Appropriateness of the recommendations"
},
{
"measure": "Semi-structured exit interviews"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Aptar Digital Health"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-27"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-03"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Virtual reality therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Rheumatic Diseases",
"Hand Rheumatism",
"Virtual Reality Therapy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Antalya",
"contacts": [
{
"email": "[email protected]",
"name": "Sebahat Yaprak Cetin, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Sebahat Yaprak Cetin",
"geoPoint": {
"lat": 36.90812,
"lon": 30.69556
},
"state": "Konyaaltı",
"status": "RECRUITING",
"zip": "07100"
}
]
},
"descriptionModule": {
"briefSummary": "Affects such as pain, swelling, tenderness, deformities, limitations, strength and function losses, skill and coordination deficiencies in the hand joints, which are frequently seen in rheumatism patients with hand involvement, are included in body structure and function disorders within the framework of International Classification of Function System. Leap Motion Controller is used in hand rehabilitation because it is small in size, low-cost, portable, non-contact, easy to use and provides visual and auditory feedback. The aim of our study is to examine the effect of technology-based rehabilitation on joint range of motion, grip strength, functionality and disease activity in adult individuals with rheumatic disease with hand involvement; and also to compare these effects with the effects of the hand rehabilitation program implemented under the guidance of a physiotherapist and the control group that continues its routine life."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "There are three groups in the study. First group is leap motion interventional group, second group is hand exercises group and the third group is waiting list.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Investigator and outcome assessors do not know which patient is in which group.",
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "64 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Technological Based Rehabilitation on Individuals With Rheumatic Disease",
"nctId": "NCT06385574",
"orgStudyIdInfo": {
"id": "2023-088",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Hand grip strength measurement"
},
{
"measure": "Jebsen Hand Function Test (JHFT)"
},
{
"measure": "Nine Hole Peg Test (NHPT)"
},
{
"measure": "Duruoz Hand Index (DHI)"
},
{
"measure": "Michigan Hand Outcome questionnaire (MHQ)"
}
],
"secondaryOutcomes": [
{
"measure": "Disease Activity Score 28 (DAS 28)"
},
{
"measure": "Hand fine grip strength measurement"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Akdeniz University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-15"
},
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"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tramadol"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Opioid-Induced Bowel Dysfunction",
"Constipation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aalborg",
"contacts": null,
"country": "Denmark",
"facility": "Aalborg University Hospital",
"geoPoint": {
"lat": 57.048,
"lon": 9.9187
},
"state": null,
"status": null,
"zip": "9000"
}
]
},
"descriptionModule": {
"briefSummary": "Tramadol is a weak opioid and widely used to treat moderate to severe pain. Stronger opioids are known to inhibit gastrointestinal motility and secretion, however the effects of tramadol on gastrointestinal function remains less understood. The aim of this study was to determine to what degree tramadol causes opioid-induced bowel dysfunction by using an objective design to explore gastrointestinal transit, motility pattern, secretion, and colonic volume, in a group of healthy male volunteers."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
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"maskingInfo": {
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},
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},
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"count": 20,
"type": "ACTUAL"
},
"phases": [
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],
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},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "20 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Influence of Tramadol on Opioid-induced Bowel Dysfunction",
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"orgStudyIdInfo": {
"id": "Tramadol_OIBD",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2022-500108-23-00",
"link": null,
"type": "CTIS"
}
]
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Total gastrointestinal transit time"
},
{
"measure": "Colorectal transit time"
}
],
"secondaryOutcomes": [
{
"measure": "Constipation symptoms"
},
{
"measure": "Bowel movement frequency"
},
{
"measure": "Stool consistency"
},
{
"measure": "Gastrointestinal symptoms"
},
{
"measure": "Opioid-induced constipation"
},
{
"measure": "Diagnostic evaluation of opioid-induced constipation"
},
{
"measure": "Colonic motility patterns"
},
{
"measure": "Opiate withdrawal symptoms"
},
{
"measure": "Colon volume"
},
{
"measure": "Colonic water content"
},
{
"measure": "Gastric half emptying time"
},
{
"measure": "Gastric contraction assessment"
},
{
"measure": "Gastric contraction assessment"
},
{
"measure": "Small bowel motility assessment"
},
{
"measure": "Small bowel water content"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Asbjørn Mohr Drewes"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-05-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-05-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-08-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lurbinectedin"
},
{
"name": "Dostarlimab"
}
]
},
"conditionsModule": {
"conditions": [
"Endometrial Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Background:Endometrial cancer is a prevalent gynecological malignancy, with a significant number of cases diagnosed at an advanced stage or recurring following initial treatment. Platinum-based chemotherapy represents a standard treatment option for these patients; however, disease progression often occurs, highlighting the need for novel therapeutic approaches. Lurbinectedin, a synthetic analog of marine alkaloid-derived compounds, and dostarlimab, a monoclonal antibody targeting PD-1, have demonstrated promising antitumor activity in various malignancies. This phase I-II clinical trial seeks to evaluate the safety, tolerability, and efficacy of combining lurbinectedin and dostarlimab in patients with advanced or recurrent endometrial cancer who have experienced disease progression following platinum-based chemotherapy.Primary Objectives:To determine the maximum tolerated dose (MTD) and recommended dose for further investigation of lurbinectedin and dostarlimab in combination therapy for advanced or recurrent endometrial cancer.To assess the antitumor activity of lurbinectedin and dostarlimab combination therapy, measured by objective response rate (ORR), in patients with advanced or recurrent endometrial cancer.Secondary Objectives:To evaluate the safety and tolerability of lurbinectedin and dostarlimab combination therapy in patients with advanced or recurrent endometrial cancer.To characterize the pharmacokinetic profile of lurbinectedin and dostarlimab when administered in combination therapy.To explore pharmacogenomic biomarkers predictive of response and/or resistance to lurbinectedin and dostarlimab combination therapy in patients with advanced or recurrent endometrial cancer.To assess progression-free survival (PFS), duration of response (DOR), clinical benefit rate (CBR), and overall survival (OS) in patients receiving lurbinectedin and dostarlimab combination therapy for advanced or recurrent endometrial cancer.To investigate the impact of lurbinectedin and dostarlimab combination therapy on quality of life and symptom control in patients with advanced or recurrent endometrial cancer."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
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"maskingInfo": {
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"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "LiDer",
"briefTitle": "Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer",
"nctId": "NCT06385548",
"orgStudyIdInfo": {
"id": "VHIO21001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximum Tolerated Dose (MTD) and Recommended Dose (RD) Determination"
},
{
"measure": "Evaluation of Lurbinectedin and Dostarlimab Combination Therapy in Advanced/Recurrent Cervical Cancer Patients"
}
],
"secondaryOutcomes": [
{
"measure": "Safety Evaluation of Lurbinectedin in combination with Dostarlimab"
},
{
"measure": "Evaluate the progression-free survival (PFS)"
},
{
"measure": "Pharmacokinetic (PK) and Pharmacogenomic Evaluation"
},
{
"measure": "Overall Response Rate (ORR)"
},
{
"measure": "Evaluate the Duration of Response (DOR)"
},
{
"measure": "Evaluate the Clinical Benefit Rate (CBR)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Vall d'Hebron Institute of Oncology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Habit Reversal Training (HRT)"
}
]
},
"conditionsModule": {
"conditions": [
"Tics",
"Tic Disorders",
"Vocal Tic",
"Motor Tic",
"Tourette Syndrome",
"Tourette Syndrome in Children",
"Tourette Syndrome in Adolescence",
"Tics/Tremor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Salt Lake City",
"contacts": [
{
"email": "[email protected]",
"name": "Kirsten Bootes, MS",
"phone": "801-585-7114",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Kirsten Bootes, MS",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Utah",
"geoPoint": {
"lat": 40.76078,
"lon": -111.89105
},
"state": "Utah",
"status": "RECRUITING",
"zip": "84112"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical study is to learn more about the timing of tics (sudden, fast movements and sounds that people do and make without meaning to) in people who have multiple tics that have been going on for more than one year. The main questions it aims to answer are:1. See whether a tic's timing is related to other characteristics of the tic, like how long it has been happening and how well the person can control/stop that tic2. See whether the timing of a tic can tell us how well the person can control/stop that tic3. See whether tic treatment changes the timing of tics, and if the timing of a tic has anything to do with how well treatment will work to stop itParticipants will meet with a study researcher to learn more about the study, ask questions, and decide whether or not they would like to be involved. If they decide to do the study, they will meet with the researcher 6 times:1. During the first visit, the study researcher will ask questions about the participant's life, tics, and other psychological symptoms. The researcher will watch the participant's tics for 10 minutes. The participant will do a computer task where they follow instructions to tic or not tic.2. During the second visit, the study researcher will treat one of the participant's tics.3. During the third visit, the study researcher will treat another one of the participant's tics.4. During the fourth visit, the study researcher will treat another one of the participant's tics.5. During the fifth visit, the study researcher will treat another one of the participant's tics.6. During the sixth visit, the study researcher will ask questions about the participant's tics and other psychological symptoms. The participant will do a computer task where they follow instructions to tic or not tic."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Clinical trial with a single arm (i.e., participants are not assigned to groups).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "The Principal Investigator and Outcomes Assessors will be blinded to the fractal properties of participants' tics until all study procedures have been completed.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "PTD",
"briefTitle": "Clinical Characteristics and Temporal Properties of Individual Tics in Persistent Tic Disorder",
"nctId": "NCT06385535",
"orgStudyIdInfo": {
"id": "IRB_00171031",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Estimates of baseline individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies"
},
{
"measure": "Voluntary tic suppression success at baseline"
},
{
"measure": "Total tic severity at baseline as measured by the Yale Global Tic Severity Scale (YGTSS)"
},
{
"measure": "Total and individual tic severity at baseline as measured by the Parent Tic Questionnaire (PTQ)"
},
{
"measure": "Changes in voluntary individual and total tic suppression success pre- and post-intervention"
},
{
"measure": "Changes in individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies pre- and post-intervention"
},
{
"measure": "Changes in individual and total tic severity pre- and post-intervention as measured by the Yale Global Tic Severity Scale (YGTSS) and Parent Tic Questionnaire (PTQ)"
}
],
"secondaryOutcomes": [
{
"measure": "Individual and total premonitory urge severity at baseline as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS)"
},
{
"measure": "Individual and total premonitory urge severity post-intervention as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS)"
},
{
"measure": "Changes in individual and total premonitory urge severity pre- and post-intervention as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS)"
},
{
"measure": "Total tic severity post-intervention as measured by the Yale Global Tic Severity Scale (YGTSS)"
},
{
"measure": "Individual and total tic severity post-intervention as measured by the Parent Tic Questionnaire (PTQ)"
},
{
"measure": "Voluntary tic suppression success post-intervention"
},
{
"measure": "Estimates of individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies post-intervention"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Utah"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-12-11",
"filename": "ICF_000.pdf",
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{
"armsInterventionsModule": {
"interventions": [
{
"name": "BITR2101"
}
]
},
"conditionsModule": {
"conditions": [
"NHL",
"Cutaneous T Cell Lymphoma",
"Peripheral T-cell Lymphoma"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The goal of this trial is to learn if a new drug, BITR2101, works to treat non-Hodgkin lymphoma (NHL) in adults, with CTCL patients being sought in particular. The trial also seeks to learn about the safety of this drug. This drug is a protein called an antibody. The drug prevents a molecule called a receptor, named TNFR2, from being made. TNFR2 regulates the immune system and provides important signals to lymphoma cells to grow, make more of themselves and survive. When the drug prevents TNFR2 from being produced in lymphoma cells from CTCL patients, those cells died in the laboratory. Therefore, the trial seeks to enroll CTCL patients in particular, in addition to other subtypes of NHL. When the drug prevents the receptor from being made in certain immune cells, there is increased immune activity. Thus, the trial will test if this drug is a new immune therapy that helps the immune system to keep lymphoma under control. In particular, we want to find out if the amount of lymphoma in the body decreases while taking the drug. Patients with autoimmune diseases are not permitted because of this potential increase in immunity brought on by this drug. Patients should have NHL that has been previously treated, that is getting worse on their current therapy, and their doctors think a new treatment is needed. All patients will receive BITR2101 by a 3 hour infusion into a vein, periodically, initially every 3 weeks. There is no placebo in this trial. Visits to the clinic facility will be required, initially at least every week and later less frequently. Patients will be expected to report changes in their health to the clinic staff including new findings and any change in the status of their lymphoma they may be aware of. Patients can continue to receive BITR2101 for up to a year or until their lymphoma worsens. For patients who are clearly benefiting, they may be able to receive BITR2101 for another year."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 37,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Clinical Trial in Adults With Non-Hodgkin Lymphoma (NHL), With a Particular Emphasis on Cutaneous T Cell Lymphoma (CTCL), Testing the Safety and Activity of a Novel Drug to Inhibit a Protein Called Tumor Necrosis Factor Receptor 2 That Drives Both Lymphoma Growth and Escape of the Immune System",
"nctId": "NCT06385522",
"orgStudyIdInfo": {
"id": "BITR2101-C-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "to assess the safety and tolerability of BITR2101 administered intravenously every 3 weeks in order to determine the MTD, if any, and to inform the RDE"
}
],
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},
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}
} | false | null |
{
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]
},
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]
},
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},
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},
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]
},
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"link": null,
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},
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},
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{
"measure": "Estrogen changes"
},
{
"measure": "Follicle Stimulating Hormone (FSH) changes."
},
{
"measure": "Luteinizing hormone (LH) changes"
},
{
"measure": "Sperm analysis"
},
{
"measure": "Sperm analysis"
},
{
"measure": "Sperm analysis"
},
{
"measure": "Testis volume analysis"
}
],
"primaryOutcomes": [
{
"measure": "CST Test"
}
],
"secondaryOutcomes": [
{
"measure": "Adrenal Insufficiency"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "ICON plc"
}
],
"leadSponsor": {
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}
},
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"date": "2026-02"
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},
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},
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"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Biopsy"
},
{
"name": "Biospecimen Collection"
},
{
"name": "Computed Tomography"
},
{
"name": "Magnetic Resonance Imaging"
},
{
"name": "Sapanisertib"
}
]
},
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"conditions": [
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"Refractory Lymphoma",
"Refractory Malignant Solid Neoplasm",
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]
},
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{
"city": "Philadelphia",
"contacts": null,
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"facility": "ECOG-ACRIN Cancer Research Group",
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},
"state": "Pennsylvania",
"status": null,
"zip": "19103"
}
]
},
"descriptionModule": {
"briefSummary": "This phase II MATCH treatment trial tests how well MLN0128 (TAK-228) works in treating patients with cancer that has certain genetic changes called mTOR mutations. MLN0128 (TAK-228) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth."
},
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},
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},
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}
} | false | null |
{
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"interventions": [
{
"name": "Afatinib"
},
{
"name": "Biopsy"
},
{
"name": "Biospecimen Collection"
},
{
"name": "Computed Tomography"
},
{
"name": "Echocardiography"
},
{
"name": "Magnetic Resonance Imaging"
},
{
"name": "Radionuclide Imaging"
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]
},
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"status": null,
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]
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"briefSummary": "This phase II MATCH treatment trial tests how well afatinib works in treating patients with cancer that has certain genetic changes. Afatinib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the EGFR gene. It works by blocking the action of mutated EGFR that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells."
},
"designModule": {
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},
{
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},
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},
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"startDateStruct": {
"date": "2015-08-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dynamic Temporal and Tactile Cueing treatment"
}
]
},
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"conditions": [
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]
},
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"locations": [
{
"city": "Kowloon",
"contacts": [
{
"email": "[email protected]",
"name": "Min Ney Wong, PhD",
"phone": "+852 2766 7268",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "The Hong Kong Polytechnic University",
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"lon": 114.18333
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"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
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"briefSummary": "The proposed study aims to investigate the efficacy of the Dynamic Temporal and Tactile Cueing treatment in Cantonese-English bilingual speakers with childhood apraxia of speech."
},
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},
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"stdAges": [
"CHILD"
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},
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"link": null,
"type": null
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},
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"measure": "Phonemes accuracy"
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{
"measure": "Stress accuracy"
},
{
"measure": "Tone accuracy"
}
],
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},
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{
"name": "University of Vermont"
},
{
"name": "The University of Hong Kong"
}
],
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}
},
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"date": "2024-08-01"
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"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mindhelper- A national youth mental health promotion website"
}
]
},
"conditionsModule": {
"conditions": [
"Mental Health Issue",
"Well-Being",
"Adolescents",
"Young Adults",
"Online Intervention",
"Internet-Based Intervention",
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},
"contactsLocationsModule": {
"locations": [
{
"city": "Copenhagen",
"contacts": [
{
"email": "[email protected]",
"name": "Sofie H Hoffmann",
"phone": "65 50 77 34",
"phoneExt": "+45",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Lau C Thygesen",
"phone": "65 50 77 71",
"phoneExt": "+45",
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "National Institute of Public Health (NIPH), University of Southern Denmark",
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"lon": 12.56553
},
"state": "Copenhagen K",
"status": null,
"zip": "1455"
}
]
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},
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"maskingDescription": "The participants are partly masked. The control group will be masked; however, the intervention group will not be masked.There is no care provider nor outcome assessor as all measures are self-reported and collected through online questionnaires.Analyses of data and interpretation of results will be done masked.",
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"maximumAge": "25 Years",
"minimumAge": "15 Years",
"sex": "ALL",
"stdAges": [
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]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effects of Mindhelper on Young People's Well-being, Psychological Functioning, and Intentions to Help-seeking",
"nctId": "NCT06385457",
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"id": "24-2933",
"link": null,
"type": null
},
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},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Body Appreciation measured by the \"2-items Short forms of the Body Appreciation Scale-2\" (2-item BAS-2SF)."
}
],
"primaryOutcomes": [
{
"measure": "General well-being measure by \"The Well-Being Index WHO-5\" (WHO5)"
}
],
"secondaryOutcomes": [
{
"measure": "Psychological functioning, measure by \"The Short Warwick-Edinburgh Mental Well-Being Scale\" (SWEMWBS)."
},
{
"measure": "Intentions to help-seeking"
}
]
},
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"collaborators": [
{
"name": "TrygFonden, Denmark"
},
{
"name": "Danske Regioner"
},
{
"name": "Jascha Fonden"
},
{
"name": "Centre for Digital Psychiatry, Mental Health Services in the Region of Southern Denmark"
}
],
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"class": "OTHER",
"name": "University of Southern Denmark"
}
},
"statusModule": {
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"date": "2025-01-31"
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},
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"date": "2025-01-31"
},
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"startDateStruct": {
"date": "2024-04-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | {
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"date": "2024-04-22",
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"label": "Statistical Analysis Plan",
"size": 353976,
"typeAbbrev": "SAP",
"uploadDate": "2024-04-22T08:21"
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]
}
} |
{
"armsInterventionsModule": {
"interventions": null
},
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"conditions": [
"Fertilization in Vitro",
"Pregnancy Loss",
"Psychological Stress",
"Post-traumatic Stress"
]
},
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"locations": [
{
"city": "Chang chun",
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{
"email": "[email protected]",
"name": "Qi Xi, doctorate",
"phone": "15804303801",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "the first hospital of Jilin University",
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},
"designModule": {
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},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "IVF Failure and Pregnancy Loss on Couples' Psychological Stress",
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"id": "2024-HS-020",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "As the number of failed IVF implants increases, does it increase the difference in anxiety and depression between couples?"
},
{
"measure": "As the number of failed IVF implants increases, does it increase the difference in fertility stress between couples?"
},
{
"measure": "Does pregnancy loss after IVF transplantation have a differential effect on anxiety and depression between couples?"
},
{
"measure": "Does pregnancy loss after IVF transplantation have a differential effect on post-traumatic stress responses between couples?"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
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"leadSponsor": {
"class": "OTHER",
"name": "The First Hospital of Jilin University"
}
},
"statusModule": {
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"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2025-05-01"
},
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"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "observational study"
}
]
},
"conditionsModule": {
"conditions": [
"Metabolic Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Cardiovascular and metabolic diseases refer to a large category of cardiovascular diseases accompanied by a series of metabolic disorders (including dyslipidemia, obesity, abnormal glucose tolerance, diabetes, hypertension, thyroid dysfunction, etc.), which is the primary cause of death and disease burden of Chinese residents.The number of deaths from atherosclerotic cardiovascular disease (ASCVD) in China is about 2.4 million, accounting for 61% of the total cardiovascular deaths, accounting for more than 40% of the all-cause deaths. In Chinese patients with coronary heart disease, 52.9% are complicated with diabetes.Despite the 1.1 million coronary stents implanted in China, there has been no reduction in cardiovascular mortality, which highlights the importance of threshold advancement and the management of metabolic risk factors.In recent years, the new concept of cardiovascular and metabolic diseases has been actively promoted at home and abroad, and the focus of prevention and treatment strategy of cardiovascular and metabolic diseases has been called for.The project proposed the concept of co-treatment of metabolic diseases based on disorders of blood pressure regulation, disorders of glucose metabolism and disorders of lipid metabolism. Subjects eligible for cardiovascular and metabolic diseases were screened, their past medical records were registered, education and diagnosis and treatment management were conducted."
},
"designModule": {
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},
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"count": 8000,
"type": "ESTIMATED"
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"phases": null,
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},
"eligibilityModule": {
"maximumAge": "70 Years",
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"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Charm",
"briefTitle": "Obeservational Cohort for Evaluating Future Cardiovascular Disease With High Metabolic Risks",
"nctId": "NCT06385431",
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"id": "Charm",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "incidence rate of cardiovascular and metabolic diseases"
},
{
"measure": "treatment rate of cardiovascular and metabolic diseases"
},
{
"measure": "control rate of cardiovascular and metabolic diseases."
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
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"class": "OTHER",
"name": "The First Affiliated Hospital with Nanjing Medical University"
}
},
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"date": "2026-04-30"
},
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"date": "2024-04-26"
},
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"date": "2026-04-30"
},
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"date": "2024-04-28"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Colonic local administration of fluorouracil with enhanced adhesion"
}
]
},
"conditionsModule": {
"conditions": [
"Colorectal Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nanjing",
"contacts": [
{
"email": null,
"name": "Faming Zhang, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The Second Affiliated Hospital of Nanjing Medical University",
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"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
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"zip": "210011"
}
]
},
"descriptionModule": {
"briefSummary": "Fluorouracil (5-FU) is a commonly used drug for colorectal cancer (CRC). Thermosensitive hydrogel presents a promising carrier for 5-FU to address challenges encountered with traditional administration methods. We propose an integrated approach utilizing colonic transendoscopic enteral tubing to cover the entire colon flexibly, coupled with a thermo-sensitive gel to enhance the adhesion of 5-FU. This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for treating CRC."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
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},
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},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Fluorouracil Treatment Via Colon for Colorectal Cancer",
"nctId": "NCT06385418",
"orgStudyIdInfo": {
"id": "WST-CRC-202404",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Objective response rate (according to RECIST1.1, investigator assessment)"
}
],
"secondaryOutcomes": [
{
"measure": "Progression-free survival"
},
{
"measure": "Overall survival"
},
{
"measure": "Disease control rate (according to RECIST1.1, investigator assessment)"
},
{
"measure": "Drop period to ensure operation resection"
},
{
"measure": "Converted resection rate"
},
{
"measure": "Actual R0 resection rate"
},
{
"measure": "The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Second Hospital of Nanjing Medical University"
}
},
"statusModule": {
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"date": "2029-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
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"date": "2028-05-01"
},
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"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment"
},
{
"name": "10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC)"
}
]
},
"conditionsModule": {
"conditions": [
"Major Depressive Disorder (MDD)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "TianHong Zhang, Doctor",
"phone": "13127577024",
"phoneExt": null,
"role": "CONTACT"
}
],
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"lon": 121.45806
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"status": null,
"zip": "200030"
}
]
},
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"briefSummary": "This study will focus on the hypothesis that repetitive transcranial magnetic stimulation (TMS) based on EEG personalized modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), and will rely on the platform of neuroimaging and function brain imaging of Shanghai Mental Health Center (SMHC), an authoritative institution in the field of mental health. We will eventually facilitate optimization of physical therapy for major depressive disorder (MDD)."
},
"designModule": {
"designInfo": {
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"interventionModelDescription": "To test the hypothesis that repetitive transcranial magnetic stimulation based on individualized EEG modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), patients were tested in a parallel controlled trial.During the treatment period, patients will be randomly grouped into the precision group, which will be treated with rTMS based on personalized modulation of EEG data, and the conventional group, which will be treated with TMS at a frequency of 10 Hz to stimulate the left dorsolateral prefrontal cortex (DLPFC).",
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},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
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"acronym": null,
"briefTitle": "Electroencephalography-based Precise Repetitive Transcranial Magnetic Stimulation Treatment",
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"orgStudyIdInfo": {
"id": "2024y0423",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
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{
"measure": "the effective rate"
}
],
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{
"measure": "complete remission rate"
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{
"measure": "alpha band spectral connectivity in electroencephalogram (EEG) parameters"
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{
"measure": "Evaluation of therapeutic effect"
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]
},
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"collaborators": [
{
"name": "National Natural Science Foundation of China"
},
{
"name": "Shanghai Municipal Science and Technology Commission"
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{
"name": "Shanghai Jiao Tong University School of Medicine"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Shanghai Mental Health Center"
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},
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"date": "2026-05"
},
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"date": "2024-04-26"
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"date": "2026-05"
},
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"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Haptic module and insole device"
}
]
},
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"conditions": [
"Parkinson Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Golden Valley",
"contacts": [
{
"email": "[email protected]",
"name": "Research Coordinator",
"phone": "651-495-6363",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Struthers Parkinson's Center",
"geoPoint": {
"lat": 45.00969,
"lon": -93.34912
},
"state": "Minnesota",
"status": null,
"zip": "55427"
},
{
"city": "Saint Paul",
"contacts": [
{
"email": "[email protected]",
"name": "Clinical Trial Coordinator",
"phone": "651-495-6363",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "HealthPartners Neuroscience Center",
"geoPoint": {
"lat": 44.94441,
"lon": -93.09327
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"state": "Minnesota",
"status": null,
"zip": "55130"
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},
"descriptionModule": {
"briefSummary": "The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. The purpose of the overall Phase II study is to: (1) Develop a production ready system, (2) Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms, and (3) Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. This study will focus on validating the system and demonstrating efficacy through in-community testing."
},
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"stdAges": [
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]
},
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"briefTitle": "Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.",
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"link": null,
"type": null
},
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},
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"date": "2024-05"
},
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}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system"
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]
},
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"conditions": [
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]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
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{
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],
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},
{
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"name": "Wei Guo",
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"phoneExt": null,
"role": "CONTACT"
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],
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"facility": "Chinese PLA Gencral Hosptial",
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},
{
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"name": "Yongsheng Gao",
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"phoneExt": null,
"role": "CONTACT"
}
],
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},
{
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"contacts": [
{
"email": null,
"name": "Wei Wang",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Xiangya Hospital of Central South University",
"geoPoint": {
"lat": 28.19874,
"lon": 112.97087
},
"state": null,
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},
{
"city": "Chengdu",
"contacts": [
{
"email": null,
"name": "Jia Hu",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "West China Hospital of Sichuan University",
"geoPoint": {
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"lon": 104.06667
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},
{
"city": "Guangzhou",
"contacts": [
{
"email": null,
"name": "Xiaoping Fan",
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"role": "CONTACT"
}
],
"country": "China",
"facility": "Guangdong Provincial Hospital of Traditional Chinese Medicine",
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"lon": 113.25
},
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},
{
"city": "Guangzhou",
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"email": null,
"name": "Guangqi Chang",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital ,Sun Yat-sen University",
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"lon": 113.25
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},
{
"city": "Harbin",
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{
"email": null,
"name": "Baodong Xie",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Harbin Medical University",
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},
{
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{
"email": null,
"name": "Xuejun Wu",
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"phoneExt": null,
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}
],
"country": "China",
"facility": "Shandong Provincial Hospital",
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},
{
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"email": null,
"name": "Kunmei Gong",
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}
],
"country": "China",
"facility": "The First People's Hospital of Yunnan Province",
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"email": null,
"name": "Weimin Zhou",
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"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The Second Affiliated Hospital Of Nanchang University",
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"lat": 28.68396,
"lon": 115.85306
},
"state": null,
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},
{
"city": "Nanjing",
"contacts": [
{
"email": null,
"name": "Xin Chen",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Nanjing First Hospital",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": null,
"status": "RECRUITING",
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},
{
"city": "Nanjing",
"contacts": [
{
"email": null,
"name": "Yongfeng Shao",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Nanjing Medical University",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": null,
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"zip": null
},
{
"city": "Qingdao",
"contacts": [
{
"email": null,
"name": "Mingjin Guo",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The Affiliated Hospital Of Qingdao University",
"geoPoint": {
"lat": 36.06488,
"lon": 120.38042
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Shanghai",
"contacts": [
{
"email": null,
"name": "Dan Zhu",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Shanghai Chest Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Shanghai",
"contacts": [
{
"email": null,
"name": "Weiguo Fu",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Zhongshan Hospital, Fudan University",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
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"status": "RECRUITING",
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},
{
"city": "Shenyang",
"contacts": [
{
"email": null,
"name": "Shijie Xin",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of China Medical University",
"geoPoint": {
"lat": 41.79222,
"lon": 123.43278
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"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Xiamen",
"contacts": [
{
"email": null,
"name": "Xijie Wu",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Xiamen Cardiovascular Hospital",
"geoPoint": {
"lat": 24.47979,
"lon": 118.08187
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Xian",
"contacts": [
{
"email": null,
"name": "Jian Zuo",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of PLA Air Force Military Medical University",
"geoPoint": {
"lat": 34.25833,
"lon": 108.92861
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Zhengzhou",
"contacts": [
{
"email": null,
"name": "Zhen Li",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "First Affiliated Hospital of Zhengzhou University",
"geoPoint": {
"lat": 34.75778,
"lon": 113.64861
},
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"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study)"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)",
"nctId": "NCT06385379",
"orgStudyIdInfo": {
"id": "WQ21-2301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of all-cause mortality and major stroke within 12 months after surgery"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of immediate technical success following surgery"
},
{
"measure": "Rate of aortic aneurysm progression under control"
},
{
"measure": "Incidence of Type I or Type III endoleak"
},
{
"measure": "Incidence of aortic covered stent graft displacement"
},
{
"measure": "Postoperative branch vessel patency rate"
},
{
"measure": "Rate of conversion to thoracotomy or secondary intervention"
},
{
"measure": "Rate of major adverse events"
},
{
"measure": "Rate of aortic aneurysm-related mortality"
},
{
"measure": "Incidence of severe adverse events"
},
{
"measure": "Incidence of device-related adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Hangzhou Endonom Medtech Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Pregnant With Complication",
"Preeclampsia",
"Preterm Birth",
"Gestational Diabetes"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is Observational study, aiming to investigate the potentiality of cffDNA and cfRNA by a non-invasive test, in combination with clinical characteristics, to establish models for early screening and predicting high-risk pregnancy of PE, SPB, and GDM in Vietnam."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1105,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Developing & Evaluating Models for Early Predicting Obstetrical Diseases in Pregnant Women by Non-invasive Prenatal Test",
"nctId": "NCT06385366",
"orgStudyIdInfo": {
"id": "GS_NP1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Characteristics of pregnant women at 1st trimester (9-13 weeks 6 days of gestation)"
},
{
"measure": "Characteristics of pregnant women at recruitment"
},
{
"measure": "Define the significant differences between cases and controls"
},
{
"measure": "The development of learning machine models"
},
{
"measure": "Evaluation of the developed models"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Medical Genetics Institute (MGI)"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Gene Solutions"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome"
}
]
},
"conditionsModule": {
"conditions": [
"Postthrombotic Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Carcassonne",
"contacts": [
{
"email": "[email protected]",
"name": "Géraldine PAOLI-CAZANAVE",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre Hospitalier de Carcassonne",
"geoPoint": {
"lat": 43.21667,
"lon": 2.35
},
"state": "Aude",
"status": null,
"zip": "11010"
},
{
"city": "Martigues",
"contacts": [
{
"email": "[email protected]",
"name": "Damien DIAS",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Cabinet libéral",
"geoPoint": {
"lat": 43.40735,
"lon": 5.05526
},
"state": "Bouches-du-Rhône",
"status": null,
"zip": "13500"
},
{
"city": "Ajaccio",
"contacts": [
{
"email": "[email protected]",
"name": "Jean-François SECONDI",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Cabinet libéral",
"geoPoint": {
"lat": 41.91888,
"lon": 8.73811
},
"state": "Corse-du-sud",
"status": null,
"zip": "20090"
},
{
"city": "Ajaccio",
"contacts": [
{
"email": "[email protected]",
"name": "Céline DE MARI",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Cabinet libéral",
"geoPoint": {
"lat": 41.91888,
"lon": 8.73811
},
"state": "Corse-du-sud",
"status": null,
"zip": "20090"
},
{
"city": "Brest",
"contacts": [
{
"email": "[email protected]",
"name": "Benjamin ESPINASSE",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre Hospitalier Universitaire de Brest",
"geoPoint": {
"lat": 48.3903,
"lon": -4.48628
},
"state": "Finistère",
"status": null,
"zip": "29069"
},
{
"city": "Toulouse",
"contacts": null,
"country": "France",
"facility": "Clinique Rive Gauche",
"geoPoint": {
"lat": 43.60426,
"lon": 1.44367
},
"state": "Haut-Garonne",
"status": null,
"zip": "31076"
},
{
"city": "Lyon",
"contacts": [
{
"email": "[email protected]",
"name": "Judith CATELLA",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hospices Civils de Lyon, Hôpital Edouard Herriot",
"geoPoint": {
"lat": 45.74848,
"lon": 4.84669
},
"state": "Rhône",
"status": null,
"zip": "69003"
},
{
"city": "Amiens",
"contacts": [
{
"email": "[email protected]",
"name": "Simon SOUDET",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre Hospitalier Universitaire Amiens Picardie",
"geoPoint": {
"lat": 49.9,
"lon": 2.3
},
"state": "Somme",
"status": null,
"zip": "830054"
},
{
"city": "Fréjus",
"contacts": [
{
"email": "[email protected]",
"name": "Hatem BOUGHIDA",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre Hospitalier de Fréjus/Saint-Raphaël",
"geoPoint": {
"lat": 43.43286,
"lon": 6.73524
},
"state": "Var",
"status": null,
"zip": "83600"
},
{
"city": "Ollioules",
"contacts": [
{
"email": "[email protected]",
"name": "Anaïs CORNE",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Polyclinique Les Fleurs",
"geoPoint": {
"lat": 43.13517,
"lon": 5.848
},
"state": "Var",
"status": null,
"zip": "83190"
},
{
"city": "Saint-Raphaël",
"contacts": null,
"country": "France",
"facility": "Centre cardio-vasculaire Esterel",
"geoPoint": {
"lat": 43.42332,
"lon": 6.7735
},
"state": "Var",
"status": null,
"zip": "83700"
},
{
"city": "Sanary-sur-Mer",
"contacts": [
{
"email": "[email protected]",
"name": "Colin RICHARD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Cabinet libéral",
"geoPoint": {
"lat": 43.11783,
"lon": 5.80007
},
"state": "Var",
"status": null,
"zip": "83110"
},
{
"city": "Six-Fours-les-Plages",
"contacts": [
{
"email": "[email protected]",
"name": "Sophia BENSEDRINE",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Cabinet libéral",
"geoPoint": {
"lat": 43.1,
"lon": 5.85
},
"state": "Var",
"status": null,
"zip": "83140"
},
{
"city": "Toulon",
"contacts": [
{
"email": "[email protected]",
"name": "Jean-Noël POGGI",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer",
"geoPoint": {
"lat": 43.12442,
"lon": 5.92836
},
"state": "Var",
"status": null,
"zip": "830054"
},
{
"city": "Avignon",
"contacts": [
{
"email": "[email protected]",
"name": "Olivier GRAS",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre Hospitalier d'Avignon",
"geoPoint": {
"lat": 43.94834,
"lon": 4.80892
},
"state": "Vaucluse",
"status": null,
"zip": "84000"
}
]
},
"descriptionModule": {
"briefSummary": "Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT), with major consequences for patient quality of life and cost of management. Identifying patients at high risk of developing PTS could be useful for its prevention and may lead to more appropriate therapeutic strategies to reduce its incidence and severity.Prognostic tools for predicting risk are very useful for choosing the optimum treatment and improving patient management and are a preliminary step before developing predictive models useful for determining sensitivity to treatment. At present, although several prognostic markers and models have been proposed, it is still difficult to predict who will develop a PTS or a moderate to severe PTS. The development of PTS is multifactorial and depends largely on the extent and severity of venous obstruction which supports the theory of thrombosis burden (DVT-Burden) as a potential prognostic marker for PTS. It therefore seems important to study the association between thrombosis burden and the occurrence of PTS.The Venous Volumetric Index or VVI (Ouriel 1999) will be used for quantifying DVT-Burden. The VVI was constructed by calculating the volume from the diameter and length of 14 venous segments from the calf veins to the inferior vena cava. The VVI has been validated for its ability to discriminate between symptomatic and asymptomatic DVT and has shown superior performance to other methods for quantifying DVT.This study aim to assess the performance of baseline DVT-burden estimated by the VVI score on ultrasound for predicting the occurrence and the severity of PTS as assessed by the Villalta scale at 6 months."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DVT-Burden",
"briefTitle": "DVT Burden and the Risk of Post-thrombotic Syndrome",
"nctId": "NCT06385353",
"orgStudyIdInfo": {
"id": "2022-CHITS-003",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ID-RCB number",
"id": "2023-A02652-43",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Disease specific health related quality of life"
},
{
"measure": "General health related quality of life"
},
{
"measure": "Coagulation and fibrinolysis markers"
},
{
"measure": "Fibrinolytic and pro-coagulant activities of microvesicles/microparticles"
}
],
"primaryOutcomes": [
{
"measure": "Presence of moderate to severe Post-thrombotic Syndrome (PTS)"
},
{
"measure": "Thrombosis burden"
}
],
"secondaryOutcomes": [
{
"measure": "Presence of moderate to severe PTS adjusted to other prognostic factors at baseline"
},
{
"measure": "Thrombosis burden adjusted to other prognostic factors at baseline"
},
{
"measure": "Presence of moderate to severe PTS adjusted to other prognostic factors at baseline and during follow-up"
},
{
"measure": "Thrombosis burden adjusted to other prognostic factors at baseline and during follow-up"
},
{
"measure": "Time to complete resolution of the thrombus as a function of thrombosis burden at baseline"
},
{
"measure": "Presence of moderate to severe PTS at baseline and at follow-up visits"
},
{
"measure": "Thrombosis burden at baseline and at follow-up visits"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Assistance Publique Hopitaux De Marseille"
},
{
"name": "F-CRIN INNOVTE Research Network"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lipikar Baume AP+M"
}
]
},
"conditionsModule": {
"conditions": [
"Actinic Keratoses"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme The purpose of this study is to observe the skin barrier function, transepidermal water loss and microbial changes in study participants with actinic field damage of both arms.It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria.A total of 20 subjects will be enrolled.The study design consists in 4-week evaluation period, with 2 visits per subject: Screening/Baseline (Day 0, Day 28 (end of Lipikar Baume AP+M application))."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Investigation of the Effect of Lipikar Baume AP+M",
"nctId": "NCT06385340",
"orgStudyIdInfo": {
"id": "CentroDerm_LRP22003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Skin hydration measured by Corneometrie"
},
{
"measure": "Transepidermal water loss measured by Tewameter®"
},
{
"measure": "Aktinic keratosis area and severity index (AKASI)"
},
{
"measure": "S. aureus colonization and S. epidermidis colonization (application area)"
},
{
"measure": "Subjects's skin aspect"
}
],
"secondaryOutcomes": [
{
"measure": "Absolute lesion count by application site"
},
{
"measure": "Olsen Grade evaluation: percentage of lesion with improvement at least 1 grade at D28 by application site"
},
{
"measure": "Number of new lesions on application area over the study period by application site"
},
{
"measure": "Symptom severity score: percentage across individual scores at each visit by application site"
},
{
"measure": "modified Treatment Satisfaction Questionnaire for Medication-9 (mTSQM-9)"
},
{
"measure": "Compliance (percentage of subjects using topical agents at all intended days, 90% of days or 75% of days)"
},
{
"measure": "Pictures at all time points"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NETWORK",
"name": "CentroDerm GmbH"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-23"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ABI-5366"
},
{
"name": "ABI-5366 Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Recurrent Genital Herpes Simplex Type 2"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Auckland",
"contacts": [
{
"email": null,
"name": "Study Principal Investigator",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "New Zealand",
"facility": "New Zealand Clinical Research",
"geoPoint": {
"lat": -36.84853,
"lon": 174.76349
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-5366 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-5366 in Part B in participants seropositive for Herpes Simplex Virus Type 2 (HSV-2) with recurrent genital herpes. Effect of food will also be evaluated in Part A."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 146,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes",
"nctId": "NCT06385327",
"orgStudyIdInfo": {
"id": "ABI-5366-101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results"
},
{
"measure": "Area Under the Plasma Concentration Time Curve (AUC) of ABI-5366"
},
{
"measure": "Maximum Observed Plasma Concentration (Cmax) of ABI-5366"
},
{
"measure": "Time to Cmax (Tmax) of ABI-5366"
},
{
"measure": "Apparent Terminal Elimination Half Life (t 1/2) of ABI-5366"
},
{
"measure": "Apparent Systemic Clearance (CL/F) of ABI-5366"
},
{
"measure": "Apparent Volume of Distribution (Vz/F) of ABI-5366"
},
{
"measure": "Dose normalized AUCs and Cmax of ABI-5366"
}
],
"secondaryOutcomes": [
{
"measure": "SAD Cohorts: Comparison of plasma AUC and Cmax between fasted and fed treatments"
},
{
"measure": "MAD Cohorts: If applicable, comparison of plasma PK profiles and parameters with and without loading doses"
},
{
"measure": "MAD Cohorts: Difference in viral shedding rate (number of anogenital swabs positive for HSV-2 DNA/total number of swabs) across treatments"
},
{
"measure": "MAD Cohorts: Difference in mean and median HSV-2 DNA copies/mL for swab samples positive for HSV-2 DNA across treatments"
},
{
"measure": "MAD Cohorts: Difference in the proportion of swab samples with HSV-2 DNA >4 log10 copies/mL across treatments (number of swabbing samples with HSV-2 DNA >4 log10 copies/mL / total number of swabs obtained)"
},
{
"measure": "MAD Cohorts: Difference in number of shedding episodes during the swabbing period across treatments"
},
{
"measure": "MAD Cohorts: Difference in duration of shedding episodes during the swabbing period across treatments"
},
{
"measure": "MAD Cohorts: Difference in subclinical shedding rate (number of swabs positive for HSV-2 DNA in the absence of lesions/total number of swabs in the absence of lesions) across treatments"
},
{
"measure": "MAD Cohorts: Difference in lesion rate during the swabbing period across treatments"
},
{
"measure": "MAD Cohorts: Difference in lesion duration during the swabbing period across treatments"
},
{
"measure": "MAD Cohorts: Difference in recurrence rate (number of reappearances of lesions during the swabbing period/total days assessed) across treatments"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Assembly Biosciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Collecting data with oral health related quality of life, dental anxiety and state anxiety"
}
]
},
"conditionsModule": {
"conditions": [
"Dental Anxiety"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bolu",
"contacts": null,
"country": "Turkey",
"facility": "Kubra Degirmenci",
"geoPoint": {
"lat": 40.73583,
"lon": 31.60611
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to evaluate the effect of the clinical removal of fixed partial dentures (FPDs) on oral health-related quality of life (OHRQoL) and the anxiety values of individuals and to determine the risk factors of high anxiety levels. 300 participants were included in this study. Six different reasons for the clinical removal of FPDs (oral examination, denture renewal, root canal treatment, tooth extraction, periodontal treatment, and composite filling restoration) were defined. Questions pertaining to the United Kingdom Oral Health-Related Quality-of-Life Measure (OHQoL-UK), the Modified Dental Anxiety Scale (MDAS), and the Spielberger State-Trait Anxiety Inventory - State (STAI-S) and Trait (STAI-T) were answered."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 300,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Cross Sectional Study on Dental Anxiety and State Anxiety Related to Removal of Fixed Partial Dentures",
"nctId": "NCT06385314",
"orgStudyIdInfo": {
"id": "Degirmenci1499",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "United Kingdom Oral Health-Related Quality-of-Life Measure"
},
{
"measure": "Modified Dental Anxiety Scale"
},
{
"measure": "Spielberger State Anxiety Inventory"
},
{
"measure": "Spielberger Trait Anxiety Inventory"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Abant Izzet Baysal University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-11-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-09-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "6-minute walk distance (6MWD) test on ambient air"
},
{
"name": "6-minute walk distance test with supplemental oxygen (approximately 3l/min, nasal)"
}
]
},
"conditionsModule": {
"conditions": [
"Lung Disease Chronic",
"Lung Diseases, Interstitial",
"Lung Diseases, Obstructive"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Zurich",
"contacts": [
{
"email": "[email protected]",
"name": "Silvia Ulrich, Prof. Dr.",
"phone": "0041 44 255 22 20",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Mona Lichtblau, Dr.",
"phone": "+41442552220",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Silvia Ulrich, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Switzerland",
"facility": "University Hospital Zürich",
"geoPoint": {
"lat": 47.36667,
"lon": 8.54999
},
"state": null,
"status": null,
"zip": "8091"
}
]
},
"descriptionModule": {
"briefSummary": "The investigators aim to study the effect of SOT in subjects with chronic lung disease in submaximal exercise."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Each participant is its own control",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 14,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy With Chronic Lung Diseases",
"nctId": "NCT06385301",
"orgStudyIdInfo": {
"id": "Lung_disease_6MWD_SOT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air"
}
],
"secondaryOutcomes": [
{
"measure": "SpO2 at rest and peak 6MWD with SOT vs. ambient air"
},
{
"measure": "Heart rate at rest and peak 6MWD with SOT vs. ambient air"
},
{
"measure": "Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air"
},
{
"measure": "Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air"
},
{
"measure": "Blood pressure at rest and peak 6MWD with SOT vs. ambient air"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Zurich"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Blood and tissue collection for immunological studies, advanced imaging."
},
{
"name": "neoadjuvant Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Soft Tissue Sarcoma Adult"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tübingen",
"contacts": [
{
"email": "[email protected]",
"name": "Vlatko Potkrajcic, MD",
"phone": "+49 7071 29",
"phoneExt": "82165",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Cihan Gani, MD",
"phone": "+49 7071 29",
"phoneExt": "82165",
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Hospital Tuebingen",
"geoPoint": {
"lat": 48.52266,
"lon": 9.05222
},
"state": "Baden-Württemberg",
"status": "RECRUITING",
"zip": "72076"
}
]
},
"descriptionModule": {
"briefSummary": "\"Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcoma\" is a prospective study with additional translational research using preoperative and postoperative tissue, blood sampling and advanced imaging."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Open Label",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas",
"nctId": "NCT06385288",
"orgStudyIdInfo": {
"id": "268/2021BO2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Description of the cellular immune status via flow-cytometrie from collected blood samples"
},
{
"measure": "Description of the cellular immune status on tissue samples ussing komplex immunohistochemie"
},
{
"measure": "Measurement of the cellular free DNA from collected blood samples"
},
{
"measure": "Measurement of HMGB1 from collected blood samples"
},
{
"measure": "Evaluation of morphological tumor characteristics (size, diffusion) with weekly MRIs"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital Tuebingen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2031-07-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-07-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-07-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vitamin K1 500 µg"
},
{
"name": "K1 1000 µg"
},
{
"name": "Vitamin K2 (MK-7) 360 µg"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Osteo Arthritis Knee"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Jean Liew, MD MS",
"phone": "617-358-9655",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Boston Medical Center, Rheumatology Clinic",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02118"
}
]
},
"descriptionModule": {
"briefSummary": "The appropriate form and dosing of vitamin K to benefit relevant outcomes in knee osteoarthritis (OA) are not known. In intervention studies for conditions other than knee OA (e.g., prevention of cardiovascular disease), the most commonly used forms and doses include phylloquinone (vitamin K1; 1000µg or 500µg daily) or menaquinone-7 (MK-7 or vitamin K2; 360µg daily). However, whether these doses are adequate to increase vitamin K to levels that ameliorate risk of adverse OA outcomes is not known. Furthermore, although some studies suggest enhanced bioavailability of MK-7 over vitamin K1, as well as extra-hepatic effects, whether this is relevant for an older population with knee OA is not known,The overall goal of this pilot randomized clinical trial (RCT) is to test different subtypes and doses of vitamin K supplementation in older adults with knee OA and to measure changes in relevant biochemical measures."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A stratified permuted block randomization will be used to assign 55 participants in a 1:1:1:1 ratio to each intervention arm. A random allocation sequence will be generated by computer in blocks of 4 or 8, stratified by sex and race.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Use of a placebo from Johnson Compounding Pharmacy (Waltham, MA) of similar appearance and taste to the vitamin K supplements will allow for masking of participants, the study PI, and other study team members to the treatment allocation.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 55,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Role of Vitamin K on Knee Osteoarthritis Outcomes",
"nctId": "NCT06385275",
"orgStudyIdInfo": {
"id": "H-44897",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in uncarboxylated matrix Gla protein (ucMGP) levels"
},
{
"measure": "Change in phylloquinone levels"
},
{
"measure": "Sufficient phylloquinone levels"
},
{
"measure": "Change in menaquinone-7 (MK-7) levels"
}
],
"secondaryOutcomes": [
{
"measure": "Study adherence"
},
{
"measure": "Participant acceptability of intervention"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Boston University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Alirocumab"
},
{
"name": "Cemiplimab"
},
{
"name": "Chemotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Non Small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "In this open-label, two-arm, randomized phase 2 clinical trial, patients with clinical stage 1B-3A non-small cell lung cancer (NSCLC) will receive neoadjuvant chemotherapy and cemiplimab every 3 weeks for 3 cycles with or without alirocumab every 4 weeks prior to surgery.Eligible patients will be randomized with equal allocation to two treatment groups. Permuted block randomization algorithm will be used for treatment assignment with stratification factors: stage (1B, 2A, 2B, 3A), and performance status (0 vs. 1).The study hypothesis is that the addition of alirocumab to neoadjuvant chemoimmunotherapy will make tumor cells more immunogenic to cytotoxic T cells, resulting in an increase in complete pathologic responses in surgically resected tumor."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 126,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "TOP 2301: Neoadjuvant Chemo for NSCLC",
"nctId": "NCT06385262",
"orgStudyIdInfo": {
"id": "Pro00114645",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Compare pathologic complete response (pCR) rate for neoadjuvant chemotherapy plus cemiplimab versus chemotherapy, cemiplimab, and alirocumab."
}
],
"secondaryOutcomes": [
{
"measure": "Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by objective response rate (ORR)"
},
{
"measure": "Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by disease-free survival (DFS)"
},
{
"measure": "Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by overall survival (OS)"
},
{
"measure": "Determine the safety of neoadjuvant chemotherapy and cemiplimab with alirocumab in early-stage non-small cell lung cancer (NSCLC)"
},
{
"measure": "Determine the tolerability of neoadjuvant chemotherapy and cemiplimab with alirocumab in early-stage non-small cell lung cancer (NSCLC)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Regeneron Pharmaceuticals"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Duke University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Navina Mini"
}
]
},
"conditionsModule": {
"conditions": [
"Bowel Dysfunction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Linköping",
"contacts": [
{
"email": "[email protected]",
"name": "Peter Wide",
"phone": "+46101031341",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Jenny Axelsson",
"phone": "+46101032432",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset",
"geoPoint": {
"lat": 58.41086,
"lon": 15.62157
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 27,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents",
"nctId": "NCT06385249",
"orgStudyIdInfo": {
"id": "NAV-0012",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Overall patient satisfaction"
}
],
"secondaryOutcomes": [
{
"measure": "Incomplete bowel emptying"
},
{
"measure": "Episodes of fecal incontinence"
},
{
"measure": "Level of independence"
},
{
"measure": "Perception of handling of the device"
},
{
"measure": "Safety outcome"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Wellspect HealthCare"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-03"
},
"studyFirstPostDateStruct": {
"date": "2024-04-26"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dupilumab"
},
{
"name": "Benralizumab"
}
]
},
"conditionsModule": {
"conditions": [
"Moderate to Severe Asthma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Scottsdale",
"contacts": [
{
"email": "[email protected]",
"name": "Karalyn Folmes, Ph.D.",
"phone": "480-301-4298",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gene R Bleecker, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Deborah A Meyers, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic",
"geoPoint": {
"lat": 33.50921,
"lon": -111.89903
},
"state": "Arizona",
"status": "RECRUITING",
"zip": "85259"
},
{
"city": "La Jolla",
"contacts": [
{
"email": "[email protected]",
"name": "Asthma Research Team",
"phone": "619-431-0995",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kelan Tantisira, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Praveen Akuthota, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of California, San Diego",
"geoPoint": {
"lat": 32.84727,
"lon": -117.2742
},
"state": "California",
"status": "RECRUITING",
"zip": "92093"
},
{
"city": "New Haven",
"contacts": [
{
"email": "[email protected]",
"name": "Katherine Spaulding",
"phone": "203-737-5572",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Geoffrey L Chupp, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Yale University",
"geoPoint": {
"lat": 41.30815,
"lon": -72.92816
},
"state": "Connecticut",
"status": "RECRUITING",
"zip": "06520"
}
]
},
"descriptionModule": {
"briefSummary": "In this study, a new method will be used to evaluate response to 2 approved biologic therapies, and assess how well each patient responds to each asthma treatment. This study will measure the response to these treatments using genomic and biologic measurements obtained from participants biosamples.By evaluating response to 2 different biologic therapies, this study has the potential to provide an in-depth understanding of the mechanisms underlying severe asthma that will inform and change treatment decisions, and may ultimately lead to a change in the way that asthma patients are evaluated for potential personalized therapies and maximize the probability that the subject will respond to treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "The study is significant in determining molecular disease endotypes in a large group of moderate to severe asthmatics. By evaluating within-person genomic level changes and response to 2 different biologic therapies, this study has the potential to provide an in-depth understanding of the mechanisms underlying severe asthma that will inform and change treatment decisions.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EPIPHANY",
"briefTitle": "Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping",
"nctId": "NCT06385236",
"orgStudyIdInfo": {
"id": "804913",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
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}
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},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Changchun GeneScience Pharmaceutical Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-13"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Psychological Tests' administration"
}
]
},
"conditionsModule": {
"conditions": [
"Glioblastoma",
"Head and Neck Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Roma",
"contacts": [
{
"email": "[email protected]",
"name": "LOREDANA DINAPOLI",
"phone": "+390630154428",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Loredana Dinapoli",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Fondazione Policlinico Universitario A. Gemelli IRCCS",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": null,
"zip": "00168"
}
]
},
"descriptionModule": {
"briefSummary": "Approximately 30% of cancer patients may experience psychopathological disorders. The most common psychopathological disorders in cancer patients are mood disorders, anxiety, depression, adjustment disorders, and suicidal ideation. Among depressive disorders, mixed depression, with the simultaneous presence of symptoms of both depressive and manic polarity, is associated to higher levels of chronicity, functional impairment and suicidality. These disorders can also be worsened by loneliness and demoralization.Patients with head and neck cancer (H\\&N-C) and Glioblastoma multiforme (GBM) have high psychological and sometimes psychiatric comorbidity probably due to the severity, poor prognosis of these cancers and harsh treatment toxicities.The most important protective factor for psychopathology is psychological resilience, which is \"the capacity of a person to protect themselves and their mental health when facing life adversities,\" such as a GBM or H\\&N-C diagnosis. Resilience is influenced by the affective temperament, which refers to basic personality traits related to behavioral and emotional reactivity to environmental stimuli. It is believed to be biologically determined and relatively stable throughout life.To date, the literature does not clarify the role of resilience and temperament in mediating the psychological profile of cancer patients. Furthermore, extensive profiling of the psychological and psychiatric profile of these patients at such a critical and pivotal moment in their journey is currently lacking in the literature.Aim of this study is to evaluate global psychological and psychiatric profile of patients affected by GBM and H\\&N-C and the eventual fluctuation over time during RT course. Conducting an early and accurate screening for potential psychopathological issues will give the opportunity to avoid factors that could: worsen patient compliance, lead to suicidal risk, and increase hospitalizations.The results obtained will be utilized for planning precocious psychological or psychiatric take-in-charge aimed at promoting psychological well-being of H\\&N-C and GBM patients."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 207,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "APPOINT",
"briefTitle": "Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer",
"nctId": "NCT06385132",
"orgStudyIdInfo": {
"id": "6447",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Distress Thermometer"
}
],
"secondaryOutcomes": [
{
"measure": "Brief Psychiatric Rating Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Plixorafenib"
},
{
"name": "Cobicistat"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Volunteer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Austin",
"contacts": [
{
"email": null,
"name": "Kristie Miller, MD",
"phone": "877-362-2608",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "PPD - Austin Research Unit",
"geoPoint": {
"lat": 30.26715,
"lon": -97.74306
},
"state": "Texas",
"status": null,
"zip": "78744"
}
]
},
"descriptionModule": {
"briefSummary": "The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixerafenib in healthy volunteers. Healthy male and female participants between the ages of 18 and 55 will be enrolled into this study. This study is looking to examine:* The effect of food on the single dose PK of plixorafenib administered with cobicistat.* The effect of cobicistat administration on the single dose PK of plixorafenib.* The safety of plixorafenib administered alone and with cobicistat in a single dose regimen in healthy participants."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Volunteers.",
"nctId": "NCT06385119",
"orgStudyIdInfo": {
"id": "F8394-101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)."
},
{
"measure": "AUC from time 0 extrapolated to infinity (AUC0-inf)."
},
{
"measure": "Maximum observed plasma concentration (Cmax)."
},
{
"measure": "Time to maximum observed plasma concentration (Tmax)."
},
{
"measure": "Terminal elimination rate constant (Kel)."
},
{
"measure": "Terminal phase half-life (t1/2)."
},
{
"measure": "Apparent oral clearance (CL/F)."
},
{
"measure": "Apparent volume of distribution (Vd/F)."
},
{
"measure": "Terminal rate constant calculated from the terminal slope of the log-linear regression of concentration with time (z)."
}
],
"secondaryOutcomes": [
{
"measure": "Cumulative amount of plixorafenib excreted in urine, calculated as the sum of the product of urine concentration and urine volume (Ae)."
},
{
"measure": "Percent of dose excreted in urine in 48 hours calculated as 100*Ae/Dose."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Fore Biotherapeutics"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-24"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Real repetitive transcranial magnetic stimulation"
},
{
"name": "Sham repetitive transcranial magnetic stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Alzheimer Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS) can improve cognitive function in Alzheimer's disease (AD), but studies on the improvement of sleep disorders in AD are limited. The aim of this study was to evaluate the effects of rTMS on sleep and cognition in patients with mild-to-moderate Alzheimer's disease (AD)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "55 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease",
"nctId": "NCT06385106",
"orgStudyIdInfo": {
"id": "rTMS in AD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cognitive funtion"
},
{
"measure": "Sleep parameters"
}
],
"secondaryOutcomes": [
{
"measure": "glymphatic system"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "First Affiliated Hospital of Zhejiang University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Eldecalcitol capsules"
},
{
"name": "Alfacalcidol tablets"
},
{
"name": "Calcium carbonate tablets"
}
]
},
"conditionsModule": {
"conditions": [
"Rheumatoid Arthritis",
"Osteoporosis",
"Osteopenia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Ying Jiang, MD",
"phone": "+86-13391701765",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Peking Union Medical College Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": "100730"
},
{
"city": "Beijing",
"contacts": [
{
"email": null,
"name": "Jian Liu",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Aerospace Central Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": null
},
{
"city": "Beijing",
"contacts": [
{
"email": null,
"name": "Baoyu Zhang",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Beijing Luhe hospital, Capital Medical University",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": null
},
{
"city": "Beijing",
"contacts": [
{
"email": null,
"name": "Lian'na Xu",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Beijing Shijingshan Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": null
},
{
"city": "Beijing",
"contacts": [
{
"email": null,
"name": "Yuhua Wang",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Beijing Shijitan Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": null
},
{
"city": "Beijing",
"contacts": null,
"country": "China",
"facility": "Beijing Shunyi hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": null
},
{
"city": "Beijing",
"contacts": [
{
"email": null,
"name": "Yi Zhao",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Xuanwu Hospital, Capital Medical University",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The study will be a multi-center, randomized, open label, parallel trial conducted in rheumatoid arthritis patients treated with glucocorticoids. After signing the informed consent, all patients will be screened as per the inclusion and exclusion criteria. Estimated 314 eligible patients will be enrolled. The enrolled patients will be randomly assigned to either Eldecalcitol group or Alfacalcidol group in a 1:1 ratio and followed up for 12 months. On-site follow up visits will be conducted at Month 6 and 12 after enrollment. The study is designed to evaluate the efficacy and safety of Eldecalcitol in preventing glucocorticoid-induced bone loss in rheumatoid arthritis patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 314,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ELEGANT",
"briefTitle": "A Study on the Prevention and Treatment of GIOP With Eldecalcitol",
"nctId": "NCT06385093",
"orgStudyIdInfo": {
"id": "EDR-IIS-003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percent change from baseline to month 12 in lumbar spine (L1-4) bone mineral density (BMD)"
}
],
"secondaryOutcomes": [
{
"measure": "Percent change from baseline to month 6 in lumbar spine (L1-4) BMD"
},
{
"measure": "Percent change from baseline in total hip BMD"
},
{
"measure": "Percent change from baseline in femoral neck BMD"
},
{
"measure": "Percent change from baseline to month 12 in broadband ultrasound attenuation (BUA) and speed of sound (SOS) measured by quantitative ultrasound (QUS)"
},
{
"measure": "Percent change from baseline in Procollagen Type 1 N-telopeptide (P1NP)"
},
{
"measure": "Percent change from baseline in Type 1 Collagen C-telopeptide (CTX)"
},
{
"measure": "Percentage of patients diagnosed with osteoporosis at month 12"
},
{
"measure": "Incidence of new vertebral fracture"
},
{
"measure": "Change from baseline in Quality of Life assessed using EQ-5D-5L"
},
{
"measure": "Change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)"
},
{
"measure": "Change from baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score"
},
{
"measure": "Percent change from baseline to month 12 in volumetric bone mineral density (vBMD) measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT)"
},
{
"measure": "Percent change from baseline to month 12 in bone microarchitecture measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT)"
},
{
"measure": "Percent change from baseline to month 12 in bone geometry measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Beijing Life oasis public service center"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Chinese SLE Treatment And Research Group"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Amivantamab"
},
{
"name": "Pembrolizumab"
},
{
"name": "Paclitaxel"
}
]
},
"conditionsModule": {
"conditions": [
"Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cleveland",
"contacts": null,
"country": "United States",
"facility": "Cleveland Clinic",
"geoPoint": {
"lat": 41.4995,
"lon": -81.69541
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "44195"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, and amivantamab in addition to paclitaxel in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 117,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "OrigAMI-4",
"briefTitle": "A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer",
"nctId": "NCT06385080",
"orgStudyIdInfo": {
"id": "61186372HNC2002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cohorts 1, 2, and 3B: Objective Response Rate"
},
{
"measure": "Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT)"
},
{
"measure": "Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity"
}
],
"secondaryOutcomes": [
{
"measure": "Cohorts 1, 2, and 3B: Duration of Response (DoR)"
},
{
"measure": "Cohorts 1, 2, and 3B: Clinical Benefit Rate (CBR)"
},
{
"measure": "Cohorts 1, 2, and 3B: Progression-free Survival (PFS)"
},
{
"measure": "Cohorts 1, 2, and 3B: Overall Survival (OS)"
},
{
"measure": "Cohorts 1, 2, and 3B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity"
},
{
"measure": "Cohort 1: Maximum Observed Serum Concentration (Cmax) of Amivantamab"
},
{
"measure": "Cohort 1: Time to Maximum Observed Serum Concentration (Tmax) of Amivantamab"
},
{
"measure": "Cohort 1: Area Under the Serum Concentration Curve Verses Time Curve From Time t1 to t2 (AUC[t1-t2]) of Amivantamab"
},
{
"measure": "Cohort 1: Area Under the Curve From Time Zero to tau (AUC[0-tau]) of Amivantamab"
},
{
"measure": "Cohort 1: Trough Serum Concentration (Ctrough) of Amivantamab"
},
{
"measure": "Cohort 1: Accumulation Ratio (R) of Amivantamab"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Janssen Research & Development, LLC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07-17"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-07-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Biolimus Coated Coronary Artery Balloon Dilation Catheter"
}
]
},
"conditionsModule": {
"conditions": [
"Coronary Artery Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world.The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter",
"nctId": "NCT06385067",
"orgStudyIdInfo": {
"id": "JW-PM-DCB-2024",
"link": null,
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},
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"measure": "Target lesion failure rate (TLF)"
}
],
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"measure": "Interventional success rate"
},
{
"measure": "Device-related cardiovascular clinical composite endpoint"
},
{
"measure": "Patient-related cardiovascular clinical composite endpoint"
},
{
"measure": "Major adverse cardiac events (MACEs)"
},
{
"measure": "Incidence of thrombotic events as defined by ARC"
}
]
},
"sponsorCollaboratorsModule": {
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},
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}
}
} | false | null |
{
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"interventions": [
{
"name": "Probiotic"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
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{
"city": "Boulogne-sur-Mer",
"contacts": [
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"email": null,
"name": "Mohamad Hage, MD",
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}
],
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},
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"name": "Christine Regimbart-Trubuil, MD",
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"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Cabinet privé Dr Regimbart-Trubuil Christine",
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},
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},
{
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"email": null,
"name": "Edouard Lacotte, MD",
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"role": "PRINCIPAL_INVESTIGATOR"
}
],
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"facility": "CHU Caen Normandie",
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},
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},
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"name": "Ellen Katranji, MD",
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"role": "PRINCIPAL_INVESTIGATOR"
}
],
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"email": null,
"name": "Pr. Nicholas Kalach, MD",
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}
],
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},
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"email": null,
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}
],
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}
],
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"email": null,
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],
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},
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{
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}
],
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},
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},
{
"city": "Saint-Jean-de-Verges",
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"email": null,
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}
],
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]
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"descriptionModule": {
"briefSummary": "The aim of this clinical trial is to assess the impact of a probiotic formulation on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention."
},
"designModule": {
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],
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"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "EPIC",
"briefTitle": "Effect of Probiotics on Infantile Colic Symptoms",
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"link": null,
"type": null
},
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"domain": "ID-RCB",
"id": "2023-A02612-43",
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},
{
"domain": "Biofortis",
"id": "PEC23063",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Safety and tolerability of the intervention"
},
{
"measure": "Change in fecal immune markers and proteins"
}
],
"primaryOutcomes": [
{
"measure": "Change in daily crying duration"
}
],
"secondaryOutcomes": [
{
"measure": "Change in crying patterns"
},
{
"measure": "Change in sleep duration"
},
{
"measure": "Change in maternal quality of life"
},
{
"measure": "Change in bowel habits"
},
{
"measure": "Change in gut microbiota composition"
},
{
"measure": "Probiotic strain recovery"
}
]
},
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"collaborators": [
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"name": "BioFortis"
}
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},
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"date": "2027-02"
},
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},
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"date": "2026-02"
},
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"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intervention group 1"
},
{
"name": "Intervention group 2"
}
]
},
"conditionsModule": {
"conditions": [
"Frailty Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kaunas",
"contacts": [
{
"email": null,
"name": "Vitalija Stonkuvienė",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Lithuania",
"facility": "LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva",
"geoPoint": {
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},
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}
]
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"descriptionModule": {
"briefSummary": "The aim of the research - to evaluate the impact of interactive physical therapy tools for functional capacity, fear of falls, motivation and quality of life after open heart surgery due to ischemic heart disease and frailty in the second stage of rehabilitation."
},
"designModule": {
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"allocation": "RANDOMIZED",
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},
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},
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"type": "ESTIMATED"
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],
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},
"eligibilityModule": {
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"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
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]
},
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"id": "BE-2-83",
"link": null,
"type": null
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},
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"primaryOutcomes": [
{
"measure": "Collecting data from the medical history"
},
{
"measure": "Frailty level by Edmonton frail scale score"
},
{
"measure": "Fear of Falling by Falls Efficacy Scale International; FES-I)."
},
{
"measure": "Quality of life by EuroQoL FiveDimensionsEQ-5D-5L."
},
{
"measure": "Motivation by Multidimensional Health Locus of Control scale"
},
{
"measure": "Change from baseline functional capacity by six minutes walking test (6MWT)"
},
{
"measure": "Change from baseline physical performance by Short Physical Performance Battery (SPPB)"
},
{
"measure": "Change from baseline muscular strength by one repetition maximum test (1RM)"
},
{
"measure": "Change from baseline grip strength by hydraulic hand dinanometer"
},
{
"measure": "Change from baseline balance parameters by Biodex Balance System SD"
},
{
"measure": "Change from baseline stance and gait parameters by Zebris Medical GmbH"
}
],
"secondaryOutcomes": [
{
"measure": "Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt)"
},
{
"measure": "Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)"
}
]
},
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"class": "OTHER",
"name": "Vitalija Stonkuvienė"
}
},
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"date": "2025-09-01"
},
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"date": "2024-04-25"
},
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"date": "2025-09-01"
},
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"startDateStruct": {
"date": "2021-05-12"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Physical activity promotion"
}
]
},
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"conditions": [
"Osteoarthritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Strassen",
"contacts": null,
"country": "Luxembourg",
"facility": "Luxembourg Institute of Health",
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"lon": 6.07333
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"state": null,
"status": null,
"zip": "1445"
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]
},
"descriptionModule": {
"briefSummary": "The main purpose of this project is to promote physical activity in patients with osteoarthritis. More specifically, this study aims to test the acceptability of an app to promote physical activity in the target population, and consequently the feasibility of such an approach.A mobile phone application - namely PIANISSIMO - will be developed specifically for this project. It aims to spread knowledge on the benefits of physical activity and collect data on how this knowledge can induce behavior changes toward a more physically active lifestyle.The intervention is delivered via the app, which will send daily notifications on physical activity and sedentary behavior, and ask the participants to set their weekly goal (i.e., daily steps). The app will also collect daily steps count and ask the participant to fill in questionnaire on pain once a week."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "pilot feasibility study",
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},
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},
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"type": "ESTIMATED"
},
"phases": [
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],
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},
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PIANISSIMO",
"briefTitle": "Physical Activity Promotion in Osteoarthritis Patients",
"nctId": "NCT06385028",
"orgStudyIdInfo": {
"id": "20230213_PIANISSIMO",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": [
{
"measure": "long-term evolution of daily steps"
}
],
"primaryOutcomes": [
{
"measure": "Weekly number of connections to the application over time"
},
{
"measure": "Response rate to the weekly questionnaires over time"
}
],
"secondaryOutcomes": [
{
"measure": "Evolution of physical activity metrics"
},
{
"measure": "influence of pain on physical activity practice"
},
{
"measure": "influence of physical activity on pain report"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Œuvre Nationale de Secours Grande Duchesse Charlotte"
}
],
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"class": "OTHER_GOV",
"name": "Luxembourg Institute of Health"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-31"
},
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"startDateStruct": {
"date": "2024-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tailored DPP Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus, Type 2",
"PreDiabetes"
]
},
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"locations": [
{
"city": "Los Angeles",
"contacts": null,
"country": "United States",
"facility": "University of California, Los Angeles",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": null,
"zip": "90095"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to enhance reach and uptake of diabetes prevention among young adults, with a focus on recruiting underserved and high-need students who face additional challenges, including food and financial insecurity.The specific aims are to: 1) Evaluate the efficacy of adolescents and young adults (AYA)-tailored version of the University of California Diabetes Prevention Program (UC DPP) for mitigating type 2 diabetes risk (i.e., weight change) in a pre/post pilot trial. The investigators hypothesize that the AYA-tailored intervention will be effective at producing 5% weight loss from baseline to program completion (at 9-months); and, 2) Assess the feasibility and acceptability of an AYA-tailored version of the UC DPP program. The investigators hypothesize that it will be feasible to recruit the desired number of participants given proposed innovative outreach strategies, and that the AYA-tailored intervention will be deemed acceptable to participants both qualitatively and in regards to their retention in the program at rates similar to the larger UC DPP.The investigators will randomize participants to the AYA-tailored DPP cohort vs control cohort. Control participants will be offered the opportunity to participate in the AYA-tailored DPP in the following academic year. Participants will be organized into groups within their DPP cohort based on their student status and/or place of residence. The intervention will include 19 sessions (18 in-person and 1 on-demand) covering 24 DPP modules; each session is approximately an hour in length and will be moderated by a lifestyle coach. At the end of each session, intervention participants will receive an email/text with a unique link to a brief REDCap survey to ascertain acceptability of the session. Control group will receive access to materials about study habits, alcohol use, and financial literacy. Control group will receive materials via e-mail for participants to review on their own time and will receive acceptability surveys. A research assistant (RA) will meet with control participants via Zoom to explain the materials. Participants will complete baseline and 9-month follow-up assessments. Participants will complete a 30 minute questionnaire via REDCap and height/weight measurements will be collected by a RA. Participants will be asked to self-report weight and physical activity at the end of the fall and winter quarter; data will be collected via brief REDCap survey."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
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},
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"primaryPurpose": "PREVENTION",
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},
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"count": 80,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "17 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "T-UP: Engaging Vulnerable Students in Diabetes Prevention",
"nctId": "NCT06385015",
"orgStudyIdInfo": {
"id": "IRB#23-001257",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in weight (pounds, lbs) between baseline and 9-month follow-up"
},
{
"measure": "Change in self-reported quality of life (Centers for Disease Control and Prevention Health-Related Quality of Life-14 item (CDC HRQOL-14)) between baseline and 9-month follow-up"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "American Diabetes Association"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of California, Los Angeles"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | {
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"largeDocs": [
{
"date": "2023-09-22",
"filename": "ICF_000.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 203319,
"typeAbbrev": "ICF",
"uploadDate": "2024-01-23T16:50"
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} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Remimazolam"
}
]
},
"conditionsModule": {
"conditions": [
"Gynecological Surgery"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Enhanced recovery after surgery (ERAS) protocols are being explored to improve patient outcomes. The method of inducing anesthesia and maintenance using inhalation anesthetics is common but may delay recovery. Remimazolam, a benzodiazepine-class drug, is noted for its rapid metabolism and fewer hemodynamic changes. Research suggests combining sevoflurane and propofol for anesthesia in adults enhances recovery, while studies in pediatric patients indicate a reduction in emergence agitation with remimazolam. However, the impact of combining sevoflurane and remimazolam on postoperative recovery in adult patients undergoing gynecologic and laparoscopic surgery is not yet studied. The study aims to compare the time to emergence from anesthesia and tracheal extubation between concurrent sevoflurane and remimazolam administration versus sevoflurane alone."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"OUTCOMES_ASSESSOR"
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"primaryPurpose": "OTHER",
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"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "19 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Combined Administration of Sevoflurane and Remimazolam on Emergence",
"nctId": "NCT06385002",
"orgStudyIdInfo": {
"id": "2024-0158",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "time to emergence"
},
{
"measure": "time to tracheal extubation"
}
],
"secondaryOutcomes": [
{
"measure": "usage of vasopressors"
},
{
"measure": "severity of cough"
},
{
"measure": "time to discharge from the recovery room"
},
{
"measure": "postoperative pain scores"
},
{
"measure": "scores for postoperative nausea and vomiting"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Pusan National University Yangsan Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-31"
},
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"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Child restraint system with load leg feature"
}
]
},
"conditionsModule": {
"conditions": [
"Motor Vehicle Injury",
"Safety Issues"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Columbus",
"contacts": [
{
"email": "[email protected]",
"name": "Julie Mansfield, PhD",
"phone": "614-366-2101",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "The Ohio State University",
"geoPoint": {
"lat": 39.96118,
"lon": -82.99879
},
"state": "Ohio",
"status": null,
"zip": "43210"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to assess the usability of a load leg design for caregivers who must install the child safety seat into a vehicle. The specific aims are to quantify any errors committed by the participants while installing the car seat and to assess participants' opinions on the car seat's load leg design."
},
"designModule": {
"designInfo": {
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},
"enrollmentInfo": {
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},
"phases": null,
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},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Safety-Enhancing Motor Vehicle Child Safety Seat",
"nctId": "NCT06384989",
"orgStudyIdInfo": {
"id": "MinnesotaHealthSolutions_LL",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Correct use of load leg"
},
{
"measure": "Load leg error types"
}
],
"secondaryOutcomes": [
{
"measure": "Other installation errors"
},
{
"measure": "Opinion on load leg design and instructions"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Minnesota HealthSolutions"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "KYV-101"
},
{
"name": "Standard lymphodepletion regimen"
},
{
"name": "Anti-CD20 mAB"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis, Primary Progressive",
"Multiple Sclerosis, Secondary Progressive",
"Multiple Sclerosis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
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},
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"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis",
"nctId": "NCT06384976",
"orgStudyIdInfo": {
"id": "KYV101-007",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To evaluate efficacy of KYV-101"
}
],
"secondaryOutcomes": [
{
"measure": "To characterize the safety and tolerability of KYV-101"
},
{
"measure": "To characterize the safety and tolerability of KYV-101"
},
{
"measure": "To characterize the safety and tolerability of KYV-101"
},
{
"measure": "To evaluate efficacy of KYV-101"
},
{
"measure": "To characterize the pharmacokinetics (PK)"
},
{
"measure": "To characterize the pharmacokinetics (PK)"
},
{
"measure": "To characterize the Pharmacodynamics (PD)"
},
{
"measure": "To characterize the Pharmacodynamics (PD)"
},
{
"measure": "To evaluate the immunogenicity (humoral response) of KYV-101"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Kyverna Therapeutics"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Atrial pacing with respiratory sinus arrhythmia (RSA) variability"
},
{
"name": "Monotonic right atrial overdrive pacing"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure With Reduced Ejection Fraction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hamilton",
"contacts": [
{
"email": "[email protected]",
"name": "Martin Stiles, MB ChB",
"phone": "+64 07 957 6080",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Kelly Henderson, BSc",
"phone": "+64 0272564243",
"phoneExt": "25015",
"role": "CONTACT"
}
],
"country": "New Zealand",
"facility": "Waikato Hospital",
"geoPoint": {
"lat": -37.78333,
"lon": 175.28333
},
"state": null,
"status": null,
"zip": "3240"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out.The main questions the trial aims to answer are:* Is the new type of pacemaker safe?* Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)?Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
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"timePerspective": null
},
"enrollmentInfo": {
"count": 54,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "22 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RSA-PACE",
"briefTitle": "Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF",
"nctId": "NCT06384963",
"orgStudyIdInfo": {
"id": "Cer22/02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of arrhythmia episodes per patient during pacing"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Avania"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Ceryx Medical Australia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ChatGPT"
},
{
"name": "patient education with traditional methods."
}
]
},
"conditionsModule": {
"conditions": [
"Carcinoma, Hepatocellular"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Taipei",
"contacts": [
{
"email": "[email protected]",
"name": "Chun-Ying Wu",
"phone": "+886-28712121",
"phoneExt": "4190",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "HSIAO-PING CHEN",
"phone": "+886-28712121",
"phoneExt": "4190",
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "Taipei Veterans General Hospital",
"geoPoint": {
"lat": 25.04776,
"lon": 121.53185
},
"state": "Beitou District",
"status": "RECRUITING",
"zip": "11217"
}
]
},
"descriptionModule": {
"briefSummary": "Liver cancer is a leading cause of cancer-related deaths in Taiwan, with its onset linked to factors like chronic liver conditions, cirrhosis, and genetic predispositions. According to the \"Barcelona Clinic Liver Cancer (BCLC)\" classification, early-stage liver cancer is demarcated by stages 0 to A. Upon such diagnosis, both patients and their families often have numerous questions and concerns, ranging from treatment choices to long-term outcomes. The research proposes a GPT-3.5-based chatbot to assist these patients by providing timely, personalized information, aiming to enrich their understanding of the disease and improve communication between patients and health professionals.The research methodology employs a Randomized Controlled Trial (RCT) design, dividing participants into a control cohort receiving standard patient education routine and an experimental cohort receiving both the AI chatbot and traditional education routine. The comparative analysis of these cohorts will determine the effectiveness of the AI intervention in improving patients' health literacy and satisfaction."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "To compare the educational effectiveness of a chatbot integrated with health education information to traditional health education methods. This comparison encompassed aspects such as the patient's health literacy and clinical satisfaction. Based on the findings, recommendations and improvements would be proposed to promote the application and development of large language models in the medical field.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The research uses a Randomized Controlled Trial (RCT) methodology, dividing patients into a control group undergoing the conventional patient education routine, and an experimental group that leverages both the chatbot and traditional education. By comparing selected outcomes between the two groups, the experiment's effectiveness will be determined.",
"whoMasked": [
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]
},
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},
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"type": "ESTIMATED"
},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluating the Role of ChatGPT in Educating Patients With Early-stage Hepatocellular Carcinoma",
"nctId": "NCT06384950",
"orgStudyIdInfo": {
"id": "2023-11-005A",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Health literacy score of patients"
},
{
"measure": "Satisfaction score with medical care"
}
],
"secondaryOutcomes": [
{
"measure": "Degree of patient anxiety"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Taipei Veterans General Hospital, Taiwan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": null,
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"contactsLocationsModule": null,
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"designModule": null,
"eligibilityModule": null,
"identificationModule": {
"acronym": null,
"briefTitle": "[Trial of device that is not approved or cleared by the U.S. FDA]",
"nctId": "NCT06384937",
"orgStudyIdInfo": {
"id": "GCA-PRO-2022-001-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": null,
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": null,
"name": "[Redacted]"
}
},
"statusModule": {
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"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "WITHHELD",
"primaryCompletionDateStruct": null,
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"startDateStruct": null,
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Raman Spectroscopy handheld probe (EmVision, FL, USA)"
},
{
"name": "Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA)"
}
]
},
"conditionsModule": {
"conditions": [
"Skin Cancer",
"Basal Cell Carcinoma",
"Squamous Cell Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Stony Brook",
"contacts": [
{
"email": "[email protected]",
"name": "Renee Cattell, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Renee Cattell, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Stony Brook Hospital",
"geoPoint": {
"lat": 40.92565,
"lon": -73.14094
},
"state": "New York",
"status": null,
"zip": "11794"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to find out if Raman Spectroscopy, a type of imaging, can be used to determine the size of skin cancer tumors. The main question it aims to answer is:-Can Raman Spectroscopy help figure out how far a tumor spreads?This study will take measurements using laser light from an experimental, handheld probe by lightly touching the skin."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Raman Spectroscopy and Skin Cancer",
"nctId": "NCT06384924",
"orgStudyIdInfo": {
"id": "SBU-RAMAN-SKINCANCER",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin."
}
],
"secondaryOutcomes": [
{
"measure": "Compare the size of clinically defined margin and Raman-defined margin"
},
{
"measure": "Compare the dose delivered to surrounding critical structures when using clinically defined margin and Raman-defined margin"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Renee Cattell"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Financial Incentives Program"
}
]
},
"conditionsModule": {
"conditions": [
"Type 1 Diabetes"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes.Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels and person-reported outcomes between groups."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 96,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "InvesT1D: Promoting Adolescent Investment in Diabetes Care",
"nctId": "NCT06384911",
"orgStudyIdInfo": {
"id": "STUDY00004543",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Time In Range"
}
],
"secondaryOutcomes": [
{
"measure": "Time Above Range"
},
{
"measure": "Time Below Range"
},
{
"measure": "Hemoglobin A1c (HbA1c)"
},
{
"measure": "Diabetes Distress"
},
{
"measure": "Diabetes Family Conflict"
},
{
"measure": "Adolescent Quality of Life"
},
{
"measure": "Caregiver Quality of Life"
},
{
"measure": "Diabetic Ketoacidosis"
},
{
"measure": "Severe Hypoglycemia"
},
{
"measure": "Insulin Adminstration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Harvard Pilgrim Health Care"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Seattle Children's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Remote Tai Chi"
}
]
},
"conditionsModule": {
"conditions": [
"Knee Osteoarthritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Sherwood Alexis, MHA, MBA",
"phone": "617-636-5405",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Chenchen Wang, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Tim McAlindon, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Tufts Medical Center",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02111"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis. The main questions the trial aims to answer are:* Does remote Tai Chi improve the extent to which pain interferes with physical, mental, and social activities (PROMIS-Pain Interference at 3 months, primary outcome), as well as knee pain and function (WOMAC subscales) and analgesic use (secondary outcomes)* Does remote tai chi decreases healthcare utilization?Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain. Participants will participate in remotely delivered web-based tai chi sessions, twice a week for 12 weeks, or will continue to receive routine care. Participants will be followed for 12 months after randomization."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The study is an individually randomized group-treatment (IRGT) trial. Individuals randomly allocated to remote Tai Chi receive the intervention with other participants through an instructor.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 480,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TAICHIKNEE",
"briefTitle": "Remote Tai Chi for Knee Osteoarthritis",
"nctId": "NCT06384898",
"orgStudyIdInfo": {
"id": "STUDY00002259",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "National Center for Complementary and Integrative Health",
"id": "UH3AT012413",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "WOMAC Pain Score"
},
{
"measure": "WOMAC Pain Score"
},
{
"measure": "WOMAC Pain Score"
},
{
"measure": "WOMAC Pain Score on nominated activity chosen at baseline"
},
{
"measure": "WOMAC Pain Score on nominated activity chosen at baseline"
},
{
"measure": "WOMAC Pain Score on nominated activity chosen at baseline"
},
{
"measure": "WOMAC function score"
},
{
"measure": "WOMAC function score"
},
{
"measure": "WOMAC function score"
},
{
"measure": "WOMAC stiffness score"
},
{
"measure": "WOMAC stiffness score"
},
{
"measure": "WOMAC stiffness score"
},
{
"measure": "Patient's global assessment score"
},
{
"measure": "Patient's global assessment score"
},
{
"measure": "Patient's global assessment score"
},
{
"measure": "PROMIS sleep disturbance OA Knee- Short Form 6a"
},
{
"measure": "PROMIS sleep disturbance OA Knee- Short Form 6a"
},
{
"measure": "PROMIS sleep disturbance OA Knee- Short Form 6a"
},
{
"measure": "Beck Depression Inventory-II score"
},
{
"measure": "Beck Depression Inventory-II score"
},
{
"measure": "Beck Depression Inventory-II score"
},
{
"measure": "SF-12 MCS score"
},
{
"measure": "SF-12 MCS score"
},
{
"measure": "SF-12 MCS score"
},
{
"measure": "Receipt of knee surgery"
},
{
"measure": "OMERACT/OARSI responder"
},
{
"measure": "OMERACT/OARSI responder"
},
{
"measure": "OMERACT/OARSI responder"
},
{
"measure": "Pain medication use"
},
{
"measure": "Pain medication use"
},
{
"measure": "Pain medication use"
}
],
"primaryOutcomes": [
{
"measure": "PROMIS Pain Interference score"
},
{
"measure": "PROMIS Pain Interference score"
},
{
"measure": "PROMIS Pain Interference score"
}
],
"secondaryOutcomes": [
{
"measure": "WOMAC total score"
},
{
"measure": "WOMAC total score"
},
{
"measure": "WOMAC total score"
},
{
"measure": "SF-12 PCS score"
},
{
"measure": "SF-12 PCS score"
},
{
"measure": "SF-12 PCS score"
},
{
"measure": "Number of knee joint injections"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Boston Medical Center"
},
{
"name": "University of California, Los Angeles"
},
{
"name": "The Cleveland Clinic"
},
{
"name": "National Center for Complementary and Integrative Health (NCCIH)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Tufts Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ultrasound"
}
]
},
"conditionsModule": {
"conditions": [
"Swimming Induced Pulmonary Edema"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Parker",
"contacts": [
{
"email": "[email protected]",
"name": "Kathryn A Vidlock, MD",
"phone": "651-226-1642",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Brady Patterson",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Harrison Steins",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Rocky Vista University",
"geoPoint": {
"lat": 39.5186,
"lon": -104.76136
},
"state": "Colorado",
"status": "RECRUITING",
"zip": "80012"
}
]
},
"descriptionModule": {
"briefSummary": "Swimming-induced pulmonary edema (SIPE) is a potentially life-threatening condition that can affect swimmers of all abilities. The pathophysiology is not well understood and early identification strategies are not established. Handheld ultrasound is a validated tool for the identification of pulmonary edema and is not well-studied in this population. Understanding the incidence of signs of pulmonary edema and its usefulness as a sign of early pulmonary edema would be beneficial This study evaluates triathletes and open water swimmers at endurance events. A validated protocol for lung ultrasound is used to identify the signs of pulmonary edema. The findings will be analyzed for differences in experience level, type of athlete, gender, age, and environmental factors. The findings may then be used in the future to aid in the early identification and treatment of athletes and military personnel in similar situations to decrease morbidity and mortality."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SIPE",
"briefTitle": "Ultrasound Investigation Into Swimming Induced Pulmonary Edema in Open Water Swimming Athletes",
"nctId": "NCT06384885",
"orgStudyIdInfo": {
"id": "2024-079",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Lung ultrasound"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Rocky Vista University, LLC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
} | false | null |
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